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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
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Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
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Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
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Pathology
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Physical Medicine
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Radiology
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General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
GCI
Laryngoscope, Endoscope
2
Product Code
GCJ
Laparoscope, General & Plastic Surgery
2
Product Code
K
23
2157
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
2
Cleared 510(K)
K
23
1400
Bladeless Trocar – Artemis Lap Cannula
2
Cleared 510(K)
K
23
1003
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
2
Cleared 510(K)
K
23
1358
Universal Seal (5-12 mm)
2
Cleared 510(K)
K
23
0359
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (2617
2
Cleared 510(K)
K
23
0886
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
2
Cleared 510(K)
K
23
1042
Disposable Laparoscopic Trocar
2
Cleared 510(K)
K
22
3718
HandX™ Self-Righting Needle Holder
2
Cleared 510(K)
K
22
3562
Xpan Universal Trocar System
2
Cleared 510(K)
K
23
0491
HandX™ Monopolar Scissors
2
Cleared 510(K)
K
23
0058
Bladeless Trocar – Artemis Lap Cannula
2
Cleared 510(K)
K
23
0605
1788 4K Camera System with Advanced Imaging Modality
2
Cleared 510(K)
K
22
3923
HOPKINS Telescopes
2
Cleared 510(K)
K
22
3593
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
2
Cleared 510(K)
K
22
2828
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
2
Cleared 510(K)
K
22
3116
8X-10-6XXX Camera Head
2
Cleared 510(K)
K
22
3759
Arthrex SynergyID Endoscopic Imaging System
2
Cleared 510(K)
K
23
0216
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
2
Cleared 510(K)
K
22
1591
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
2
Cleared 510(K)
K
22
1861
FloNavi Endoscopic Fluorescence Imaging System
2
Cleared 510(K)
K
22
1781
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
2
Cleared 510(K)
K
21
3597
MultiCut Solo
2
Cleared 510(K)
K
22
1252
Scivita 4KINSIGHT ICG Imaging System
2
Cleared 510(K)
K
22
2011
HandX Instrument - Monopolar Spatula
2
Cleared 510(K)
K
22
1004
HOPKINS Telescopes
2
Cleared 510(K)
K
22
2575
HurriChem Device Kit
2
Cleared 510(K)
K
21
2736
Canady Flex RoboWrist
2
Cleared 510(K)
K
22
2504
H1
2
Cleared 510(K)
K
22
1740
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
2
Cleared 510(K)
K
22
2890
RADIANCE ULTRA 32 4K ZEROWIRE DUO
2
Cleared 510(K)
K
22
2079
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
2
Cleared 510(K)
K
22
1533
Plasma Shield
2
Cleared 510(K)
K
22
1365
LapBox Tissue Containment Removal System
2
Cleared 510(K)
K
22
2130
1688 4K Camera System with Advanced Imaging Modality
2
Cleared 510(K)
K
21
3818
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
2
Cleared 510(K)
K
21
1148
CORE-Trocar
2
Cleared 510(K)
K
22
1217
SPY Laparoscope
2
Cleared 510(K)
K
21
4046
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
2
Cleared 510(K)
K
22
0895
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
2
Cleared 510(K)
K
22
0872
Saberscope5 Laparoscope
2
Cleared 510(K)
K
21
1043
Alexis Contained Extraction System
2
Cleared 510(K)
K
21
3860
ArthroFree Wireless Surgical Camera System
2
Cleared 510(K)
K
22
0069
4K UHD LCD Monitor OEV321UH
2
Cleared 510(K)
K
22
0108
SDC4K Information Management System with Device and Voice Control Package
2
Cleared 510(K)
K
21
2055
Connected OR Hub with Device and Voice Control
2
Cleared 510(K)
K
21
2500
ArtiSential Trocar
2
Cleared 510(K)
K
21
2950
FUJIFILM Video Laparoscope EL-R740M30
2
Cleared 510(K)
K
21
1577
SoftFix Balloon Trocar
2
Cleared 510(K)
K
21
2511
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
2
Cleared 510(K)
K
21
1234
RedEx
2
Cleared 510(K)
K
21
2214
HandX
2
Cleared 510(K)
K
21
0248
Lab Bag with Fabric Pouch
2
Cleared 510(K)
K
20
2582
Arthrex SynergyID Endoscopic Imaging System
2
Cleared 510(K)
K
20
3717
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
2
Cleared 510(K)
K
20
2551
Cor-Knot Micro
2
Cleared 510(K)
K
21
1250
VisionPort System
2
Cleared 510(K)
K
21
0495
Port Access System
2
Cleared 510(K)
K
21
0088
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
2
Cleared 510(K)
K
21
0584
SDC3 HD Information Management System with Wireless Device Control Capability
2
Cleared 510(K)
K
20
3255
4K UHD Laparoscope
2
Cleared 510(K)
K
20
2303
CORE E3 Suction/irrigator
2
Cleared 510(K)
K
20
3603
Monopolar Hook
2
Cleared 510(K)
K
20
1526
TIPCAM1 Rubina Video Endoscope System
2
Cleared 510(K)
K
20
2931
Disposable Trocar
2
Cleared 510(K)
K
20
2592
Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)
2
Cleared 510(K)
K
20
1134
Arthrex NanoScope System
2
Cleared 510(K)
K
20
1805
VersaOne Reusable Positioning Trocar System
2
Cleared 510(K)
K
20
2130
FUJIFILM Video Laparoscope
2
Cleared 510(K)
K
20
1641
Disposable Laparoscope Trocar
2
Cleared 510(K)
K
19
2499
Cyber Blade
2
Cleared 510(K)
K
20
1434
Connected OR Hub with Voice Control, Connected OR Hub with Device Control
2
Cleared 510(K)
K
20
1198
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
2
Cleared 510(K)
K
20
1243
Disposable Specimen Retrieval Bag
2
Cleared 510(K)
K
19
3272
GTK Trocars
2
Cleared 510(K)
K
20
1593
Looking Glass 4K Integrated Visualization System
2
Cleared 510(K)
K
20
1151
O-Mec 690 Series Laparoscopes
2
Cleared 510(K)
K
20
0902
ClickClean
2
Cleared 510(K)
K
19
1866
GelPOINT Mini Advanced Access Platform
2
Cleared 510(K)
K
20
0053
DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
2
Cleared 510(K)
K
19
3161
Pristine Scope
2
Cleared 510(K)
K
19
1930
7 mm Extended Length Endoscope
2
Cleared 510(K)
K
20
0517
Standard Trocar
2
Cleared 510(K)
K
19
3026
Visera Elite II Video System Center, Visera Elite II Endoeye 3D
2
Cleared 510(K)
K
19
2300
EnlightenVue Microendoscopy System
2
Cleared 510(K)
K
20
0310
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
2
Cleared 510(K)
K
19
2918
Video Laparoscope, Video Processor, Light Source
2
Cleared 510(K)
K
20
0228
ClearCam System
2
Cleared 510(K)
K
19
3315
Xenocor Articulating Xenoscope Laparoscope
2
Cleared 510(K)
K
19
1678
IP Converter
2
Cleared 510(K)
K
19
3137
EASYGRIP FLO-41 Precision MIS Delivery System
2
Cleared 510(K)
K
19
2643
Dannik Laparoscopic Suction Irrigation System
2
Cleared 510(K)
K
19
2891
Laparoscope Lens Shield Device (LENS)
2
Cleared 510(K)
K
19
0029
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
2
Cleared 510(K)
K
18
3675
3D Visualization System
2
Cleared 510(K)
K
19
2172
Connected OR Hub with Device and Voice Control
2
Cleared 510(K)
K
19
1177
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
2
Cleared 510(K)
K
19
1295
Percutaneous Introducer Needle
2
Cleared 510(K)
K
19
0645
Arthrex NanoScope System
2
Cleared 510(K)
K
19
1043
da Vinci Handheld Camera
2
Cleared 510(K)
K
19
0831
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
2
Cleared 510(K)
K
19
0592
YelloPort Elite Port Access System
2
Cleared 510(K)
K
19
0788
Disposable Standard Clamp
2
Cleared 510(K)
K
18
1173
ELMED Laparoscopic Instruments and Accessories
2
Cleared 510(K)
K
18
3600
Anchor Bag-Alone Tissue Retrieval System by ConMed
2
Cleared 510(K)
K
18
3264
Flex-THOR scope
2
Cleared 510(K)
K
18
2434
LaparoGuard
2
Cleared 510(K)
K
18
2606
PINPOINT Endoscopic Fluorescence Imaging System
2
Cleared 510(K)
K
17
3917
neoClose PDS
2
Cleared 510(K)
K
18
2160
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
2
Cleared 510(K)
K
18
1258
ConnectedOR Hub with Device and Voice Control
2
Cleared 510(K)
K
18
1608
Disposable Standard Clamp
2
Cleared 510(K)
K
18
2080
Scope Antifogging System
2
Cleared 510(K)
K
17
3822
Anchor Tissue Retrieval System by CONMED
2
Cleared 510(K)
K
18
2024
Dissecting Balloon System
2
Cleared 510(K)
K
18
1791
SIMPLYSTRONG, SIMPLYEZEE
2
Cleared 510(K)
K
18
1395
Universal Cannula Seal (5-12 mm)
2
Cleared 510(K)
K
18
0977
KARL STORZ New Generation Trocars
2
Cleared 510(K)
K
18
0836
Genistrong
2
Cleared 510(K)
K
18
0208
Disposable Endoscopic Trocar
2
Cleared 510(K)
K
18
0114
AEON Retrieval Bag
2
Cleared 510(K)
K
17
3919
HX Device
2
Cleared 510(K)
K
18
0579
Ezee Retrieval
2
Cleared 510(K)
K
17
1939
ALVUE Balloon Dilation System
2
Cleared 510(K)
K
17
0683
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
2
Cleared 510(K)
K
17
3272
Ergonomic Handle
2
Cleared 510(K)
K
17
2789
Specimen Retrieval Bag
2
Cleared 510(K)
K
17
2578
Equipment Pouch
2
Cleared 510(K)
K
17
2618
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
2
Cleared 510(K)
K
17
2794
Suction Irrigation Set
2
Cleared 510(K)
K
17
2038
Trocar
2
Cleared 510(K)
K
17
2940
ANCHOR Tissue Retrieval System
2
Cleared 510(K)
K
17
2672
Endoscopic Applicator, 41 cm
2
Cleared 510(K)
K
17
1726
LapBag
2
Cleared 510(K)
K
17
1741
Laport
2
Cleared 510(K)
K
17
1475
DeRoyal Laprador Specimen Retrieval System
2
Cleared 510(K)
K
17
0379
Disposable Standard Clamp
2
Cleared 510(K)
K
17
1344
Xenocor Xenoscope Laparoscopic System
2
Cleared 510(K)
K
17
0899
27HJ713S
2
Cleared 510(K)
K
17
0598
ZeroWire Mobile
2
Cleared 510(K)
K
17
0030
NOVATECH TALCAIR
2
Cleared 510(K)
K
16
2836
FUJIFILM Surgical System
2
Cleared 510(K)
K
17
0084
InterLock Trocar
2
Cleared 510(K)
K
16
3654
VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
2
Cleared 510(K)
K
17
0103
Laparoscope Lens Shield Device (LENS)
2
Cleared 510(K)
K
16
2197
EndoClot
2
Cleared 510(K)
K
16
2387
U-IGNITE Bladeless Trocar
2
Cleared 510(K)
K
16
3102
ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
2
Cleared 510(K)
K
16
0801
Well Lead Extraction Bag
2
Cleared 510(K)
K
15
3773
Disposal Lens Cleaning Sheath
2
Cleared 510(K)
K
16
1720
Standard Clamp
2
Cleared 510(K)
K
16
2445
LiVac Retractor System
2
Cleared 510(K)
K
16
2584
VersaOne Bladeless Trocar
2
Cleared 510(K)
K
16
2059
EZEE RETRIEVAL
2
Cleared 510(K)
K
16
1838
Xenocor Xenoscope Laparoscopic System
2
Cleared 510(K)
K
16
1792
PINPOINT Endoscopic Fluorescence Imaging System
2
Cleared 510(K)
K
15
3542
Pelican Sling Retractor
2
Cleared 510(K)
K
16
2077
Laparoscopic Spray Applicator with Spinning Luers
2
Cleared 510(K)
K
16
1421
Single Use Surgical Suction Irrigator
2
Cleared 510(K)
K
16
1122
Sony IP Converter NU-IP40S
2
Cleared 510(K)
K
15
3606
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
2
Cleared 510(K)
K
16
1228
Radiance Ultra Series ZeroWire Embedded
2
Cleared 510(K)
K
16
0393
AdTec
2
Cleared 510(K)
K
15
0956
PINPOINT Endoscopic Fluorescence Imaging System
2
Cleared 510(K)
K
16
0332
Stryker SDC3 HD Information Management System with Wireless Device Control Capability
2
Cleared 510(K)
K
16
1017
True HD 3MOS Camera System
2
Cleared 510(K)
K
15
2619
Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
2
Cleared 510(K)
K
16
0172
Laparoscope Lens Shield Device
2
Cleared 510(K)
K
15
1832
NOVATECH TALCAIR
2
Cleared 510(K)
K
16
0230
VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
2
Cleared 510(K)
K
15
3218
Arthrex Synergy UHD4 System
2
Cleared 510(K)
K
15
1036
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
2
Cleared 510(K)
K
15
2400
General & Plastic Surgery Instruments
2
Cleared 510(K)
K
15
2149
VersaOne Bladed Trocar 5mm
2
Cleared 510(K)
K
15
2513
8X-10-XXXX Camera System
2
Cleared 510(K)
K
15
3126
da Vinci Xi Hasson Cone
2
Cleared 510(K)
K
15
2848
AUTOLAP SYSTEM
2
Cleared 510(K)
K
15
1609
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
2
Cleared 510(K)
K
15
1489
Retrieval bag system
2
Cleared 510(K)
K
15
2663
Bladeless Optical Obturators
2
Cleared 510(K)
K
15
2565
Auto Suture Locking Trocar
2
Cleared 510(K)
K
14
3640
KSEA CMOS Camera System (C-cam)
2
Cleared 510(K)
K
15
1990
Tissue Removal System
2
Cleared 510(K)
K
15
1822
ab medica irrigation/suction gravity system
2
Cleared 510(K)
K
15
1117
Laparoscope Lens Shield Device
2
Cleared 510(K)
K
14
1594
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
2
Cleared 510(K)
K
15
0377
Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
2
Cleared 510(K)
K
15
1548
VersaOne Bladed Trocar, VersaOne Bladeless Trocar
2
Cleared 510(K)
K
15
0781
Tissue Removal Pouch
2
Cleared 510(K)
K
15
1356
Spacemaker Pro Access and Dissector System
2
Cleared 510(K)
K
15
0569
LaparoVue
2
Cleared 510(K)
K
15
0549
Reactor(TM) Trocar and Sleeve
2
Cleared 510(K)
K
14
1902
LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER
2
Cleared 510(K)
K
15
0633
ULTRA Telescopes
2
Cleared 510(K)
K
15
0705
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator
2
Cleared 510(K)
K
15
0253
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
2
Cleared 510(K)
K
14
1715
GLOVE PORT
2
Cleared 510(K)
K
14
2464
Entriport
2
Cleared 510(K)
K
15
0127
Laparoscopic Handles with peek Insulation
2
Cleared 510(K)
K
14
3299
Percuvance(R) Percutaneous Surgical System
2
Cleared 510(K)
K
14
2427
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25
2
Cleared 510(K)
K
14
0593
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
2
Cleared 510(K)
K
14
2547
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
2
Cleared 510(K)
K
14
3221
Schoelly Laparoscope
2
Cleared 510(K)
K
14
3091
Surgisleeve Wound Protector
2
Cleared 510(K)
K
14
1593
UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
2
Cleared 510(K)
K
14
2903
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
2
Cleared 510(K)
K
14
2603
Stryker Precision HD Camera System
2
Cleared 510(K)
K
14
1272
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR
2
Cleared 510(K)
K
14
1592
UNIMICRO SUCTION IRRIATION TUBING SET
2
Cleared 510(K)
K
14
0101
ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
2
Cleared 510(K)
K
13
2375
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
2
Cleared 510(K)
K
14
0662
FLEX ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
14
1323
VTI SUCTION IRRIGATION SYSTEM
2
Cleared 510(K)
K
13
3272
VERSACUT + TISSUE MORCELLATOR
2
Cleared 510(K)
K
13
3203
SINGLE-SITE PORT
2
Cleared 510(K)
K
13
3345
REVEEL ENDOSCOPIC RETRACTOR
2
Cleared 510(K)
K
13
3845
8MM TROCAR KIT
2
Cleared 510(K)
K
13
3375
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
2
Cleared 510(K)
K
13
2785
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
2
Cleared 510(K)
K
12
3728
RETRIEVAL BAG
2
Cleared 510(K)
K
13
1375
AUTOLAP SYSTEM
2
Cleared 510(K)
K
13
2169
SURGIQUEST AIRSEAL IFS
2
Cleared 510(K)
K
13
0826
PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER
2
Cleared 510(K)
K
13
1688
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
2
Cleared 510(K)
K
13
1115
ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
2
Cleared 510(K)
K
12
3280
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
2
Cleared 510(K)
K
12
3467
VS3
2
Cleared 510(K)
K
13
0121
SHORT PORT BLUNT TIP TROCAR
2
Cleared 510(K)
K
13
0435
VERSAPORT V2 BLADELESS OPTICAL TROCAR
2
Cleared 510(K)
K
12
3325
Medafor Direct Gas-Assisted Application System
2
Cleared 510(K)
K
12
3110
PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
2
Cleared 510(K)
K
12
3847
MALLEABLE TIP ENDOSCOPIC APPLICATOR
2
Cleared 510(K)
K
12
3102
SOVEREIGN MINI
2
Cleared 510(K)
K
12
2526
360 GAS ASSISTED ENDOSCOPIC APPLICATOR
2
Cleared 510(K)
K
12
2299
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
2
Cleared 510(K)
K
12
1796
WECK REUSABLE OBTURATOR
2
Cleared 510(K)
K
12
2511
ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH
2
Cleared 510(K)
K
12
0012
INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
2
Cleared 510(K)
K
12
1893
STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
2
Cleared 510(K)
K
12
0278
WIRELESS IMAGE TRANSMITTER UNIT
2
Cleared 510(K)
K
12
0468
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
2
Cleared 510(K)
K
12
1701
SYSTEMS INTEGRATION
2
Cleared 510(K)
K
12
0611
SONY PVM-2551MD OLED MONITOR
2
Cleared 510(K)
K
11
2621
WIS1000
2
Cleared 510(K)
K
12
1380
WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
2
Cleared 510(K)
K
12
0403
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
2
Cleared 510(K)
K
12
0061
WOUND PROTECTOR
2
Cleared 510(K)
K
12
0608
ENDOSCOPIC APPLICATOR
2
Cleared 510(K)
K
11
2659
SURGICAL RETRACTORS
2
Cleared 510(K)
K
11
3203
SONY LMD-2451MT LCD MONITOR
2
Cleared 510(K)
K
11
2358
UNIMAX TROCAR SYSTEM
2
Cleared 510(K)
K
11
2456
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
2
Cleared 510(K)
K
11
1845
THE ESPINER SAC OR E SAC
2
Cleared 510(K)
K
11
2349
VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
2
Cleared 510(K)
K
10
1733
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
2
Cleared 510(K)
K
10
3509
UNIMAX SUCTION IRRIGATION SET
2
Cleared 510(K)
K
11
0121
WEXLER ENDOSCOPE ACCESSORIES
2
Cleared 510(K)
K
11
0257
DIAMOND-FLEX(R) GRASPERS
2
Cleared 510(K)
K
10
3510
UNIMAX SPECIMEN RETRIEVAL SYSTEM
2
Cleared 510(K)
K
10
2839
SPIDER STANDARD AND ADVANCED
2
Cleared 510(K)
K
10
3741
SURGISURE TISSUE REMOVAL SYSTEM
2
Cleared 510(K)
K
10
3253
SILS PORT
2
Cleared 510(K)
K
10
0533
VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
2
Cleared 510(K)
K
10
1077
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
2
Cleared 510(K)
K
10
2379
LTF-Y0009; MAJ-YOO41; XOEV-3D1
2
Cleared 510(K)
K
10
2646
SPIDER FLEX MONOPOLAR HOOK
2
Cleared 510(K)
K
10
1193
PMC LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
10
2219
SOCORRO SMI TUNNEL RELEASE DEVICE
2
Cleared 510(K)
K
10
0442
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
2
Cleared 510(K)
K
10
1810
3DHJD CAMERA SYSTEM MODEL
2
Cleared 510(K)
K
09
3783
INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT
2
Cleared 510(K)
K
09
3785
MODULAR ENDOSCOPE
2
Cleared 510(K)
K
10
1937
HYBRID TROCAR SYSTEM
2
Cleared 510(K)
K
10
0109
LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE
2
Cleared 510(K)
K
10
1671
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
2
Cleared 510(K)
K
10
0045
OCTO
2
Cleared 510(K)
K
09
2789
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
2
Cleared 510(K)
K
10
0180
SURGIQUEST ANCHORPORT SIL KIT
2
Cleared 510(K)
K
10
0548
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
2
Cleared 510(K)
K
10
0959
SPECIMEN RETRIEVAL SYSTEM
2
Cleared 510(K)
K
10
0195
NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X
2
Cleared 510(K)
K
09
3279
NAVIX ACCESS DEVICE
2
Cleared 510(K)
K
09
2584
LAPORT
2
Cleared 510(K)
K
10
0346
ENDOCLEAR SYSTEM
2
Cleared 510(K)
K
09
3624
OPTISCAN MODEL OPTISCAN CEIS
2
Cleared 510(K)
K
09
3194
MGB DISPOSABLE RETRIEVAL BAG LAPBAG
2
Cleared 510(K)
K
09
3449
MINI LAP RETRACTORS
2
Cleared 510(K)
K
09
2821
TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021
2
Cleared 510(K)
K
09
2684
LAPAROSCOPIC RETRACTORS
2
Cleared 510(K)
K
09
3372
SILS PORT MODEL SILSPT15
2
Cleared 510(K)
K
09
2504
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM
2
Cleared 510(K)
K
09
1697
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
2
Cleared 510(K)
K
09
1930
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB
2
Cleared 510(K)
K
09
1350
ESTECH HAWKEYE INTRODUCER SYSTEMS
2
Cleared 510(K)
K
09
1211
EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS
2
Cleared 510(K)
K
09
1869
SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS
2
Cleared 510(K)
K
09
1648
NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
2
Cleared 510(K)
K
09
0902
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003
2
Cleared 510(K)
K
09
1515
SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM
2
Cleared 510(K)
K
09
0792
MITAKA UNIARM
2
Cleared 510(K)
K
09
0979
DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
2
Cleared 510(K)
K
09
0340
FREEHAND
2
Cleared 510(K)
K
09
0677
INNOPORT LAPAROSCOPIC ACCESS DEVICE
2
Cleared 510(K)
K
09
0631
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
2
Cleared 510(K)
K
08
2796
SOPRO 184 CAMERA
2
Cleared 510(K)
K
08
2735
STONE GRASPING BASKET, MODEL PD-T1 2115
2
Cleared 510(K)
K
08
3218
TC ENDO PORT
2
Cleared 510(K)
K
09
0275
GELPORT SINGLE INCISION ACCESS SYSTEM
2
Cleared 510(K)
K
08
3194
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
2
Cleared 510(K)
K
08
2291
A-LAP SET (A-LAP, EZAXESS, TROCAR)
2
Cleared 510(K)
K
08
3638
FIXATION TROCARS
2
Cleared 510(K)
K
08
2233
VIKY
2
Cleared 510(K)
K
08
3211
AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
2
Cleared 510(K)
K
08
2322
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
2
Cleared 510(K)
K
08
2619
SILS PORT, MODELS SILSPT5, SILSPT12
2
Cleared 510(K)
K
08
1995
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
2
Cleared 510(K)
K
08
2156
ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
2
Cleared 510(K)
K
08
0161
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
2
Cleared 510(K)
K
08
1169
AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR
2
Cleared 510(K)
K
08
0257
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
08
0977
3 CCD ENDOCAM 5550
2
Cleared 510(K)
K
07
2749
SIALO BALLOON DILATATION CATHETER
2
Cleared 510(K)
K
08
0654
PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY
2
Cleared 510(K)
K
07
2811
MARIONETTE SA, MODEL 001 001 & 001 002
2
Cleared 510(K)
K
07
2613
DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
2
Cleared 510(K)
K
08
0051
VIRTUAL PORTS ENDOCLEAR SYSTEM
2
Cleared 510(K)
K
08
0155
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
2
Cleared 510(K)
K
07
3279
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
2
Cleared 510(K)
K
07
3719
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE
2
Cleared 510(K)
K
07
3009
ONEPORT SURGICAL TROCAR SYSTEM
2
Cleared 510(K)
K
07
3170
R-PORT II LAPAROSCOPIC ACCESS DEVICE
2
Cleared 510(K)
K
07
2912
SOPRO 225 DUAL HALOGEN LIGHT SOURCE
2
Cleared 510(K)
K
07
2715
REALHAND HIGH DEXTERITY INSTRUMENTS
2
Cleared 510(K)
K
07
2674
KII TROCAR SYSTEM
2
Cleared 510(K)
K
07
0158
R-PORT LAPAROSCOPIC ACCESS DEVICE
2
Cleared 510(K)
K
07
1756
ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
2
Cleared 510(K)
K
07
1571
SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
2
Cleared 510(K)
K
07
1292
VIEW MD OFFICE SYSTEM, MODEL 41066.5540
2
Cleared 510(K)
K
07
1488
REALHAND HIGH DEXTERITY (HD) INSTRUMENTS
2
Cleared 510(K)
K
07
0198
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02
2
Cleared 510(K)
K
07
0712
MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
2
Cleared 510(K)
K
07
0509
FISSO HOLDING SYSTEM
2
Cleared 510(K)
K
06
3859
SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA
2
Cleared 510(K)
K
07
0266
560 HIGH DEFINITION CAMERA SYSTEM
2
Cleared 510(K)
K
07
0102
SOPRO 162 CAMERA
2
Cleared 510(K)
K
06
3528
TROCASYS
2
Cleared 510(K)
K
06
2968
LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES
2
Cleared 510(K)
K
06
3457
TRUEHD (1080P) DIGITAL CAMERA SYSTEM
2
Cleared 510(K)
K
06
2727
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
2
Cleared 510(K)
K
06
2209
BASX BLADELESS TROCAR
2
Cleared 510(K)
K
06
2779
DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)
2
Cleared 510(K)
K
06
0182
TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE
2
Cleared 510(K)
K
06
2326
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
2
Cleared 510(K)
K
06
1555
ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
2
Cleared 510(K)
K
06
1666
CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX
2
Cleared 510(K)
K
06
2050
FLEXVIEW SYSTEM
2
Cleared 510(K)
K
06
1180
KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
2
Cleared 510(K)
K
06
0233
TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
06
1292
STATARIUS, MODEL 001 003
2
Cleared 510(K)
K
05
3382
LAPARO-THORACO VIDEOSCOPE XLTF-VAW
2
Cleared 510(K)
K
05
1073
MIDIVIEW SERIES OF MICROENDOSCOPES
2
Cleared 510(K)
K
06
0085
STRYKER SCOPE/INSTRUMENT HOLDER
2
Cleared 510(K)
K
06
0717
NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM
2
Cleared 510(K)
K
06
0777
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
2
Cleared 510(K)
K
06
0629
GELPORT BLUNT TIP TROCAR SYSTEM
2
Cleared 510(K)
K
06
0534
INTUITIVE SURGICAL SEAL
2
Cleared 510(K)
K
05
3311
STRYKER SCOPE WARMER
2
Cleared 510(K)
K
06
0096
MODULAR TROCAR SYSTEM
2
Cleared 510(K)
K
06
0051
SPECIMEN RETRIEVAL SYSTEM
2
Cleared 510(K)
K
05
0209
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
2
Cleared 510(K)
K
05
2740
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
2
Cleared 510(K)
K
05
1585
F-400 SYSTEM
2
Cleared 510(K)
K
05
1732
ENDOSCOPIC APPLICATOR
2
Cleared 510(K)
K
05
1610
HANS HERMANN LAPAROSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
05
0650
NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000
2
Cleared 510(K)
K
05
0051
ARMAND ENDOSCOPE HOLDER
2
Cleared 510(K)
K
05
0829
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
2
Cleared 510(K)
K
05
0639
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
2
Cleared 510(K)
K
05
0163
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE
2
Cleared 510(K)
K
04
3541
ENDOLINK TRUE MOVEMENT SYSTEM
2
Cleared 510(K)
K
04
3284
ENDOASSIST
2
Cleared 510(K)
K
04
2834
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
2
Cleared 510(K)
K
05
0027
LAPAROCISION SCOPE CONTROLLER SYSTEM
2
Cleared 510(K)
K
04
2923
MD-6W WIRELESS CRITICAL DATA VIEWER
2
Cleared 510(K)
K
04
1967
GENICON SUCTION IRRIGATION SYSTEM
2
Cleared 510(K)
K
04
2069
INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
2
Cleared 510(K)
K
04
2741
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
2
Cleared 510(K)
K
04
2740
ISC-1000 PENTAX CONFOCAL LASER SYSTEM
2
Cleared 510(K)
K
04
2412
MODIFIED SPACEMAKER SYSTEM
2
Cleared 510(K)
K
04
1795
MODIFICATION TO OPTICAL SEPARATOR SYSTEM
2
Cleared 510(K)
K
03
3132
STRYKER SWITCHPOINT INFINITY
2
Cleared 510(K)
K
04
1827
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
2
Cleared 510(K)
K
04
1641
DAVOL DELIVERY SYSTEM
2
Cleared 510(K)
K
04
0604
INNERVUE DIAGNOSTIC SCOPE SYSTEM
2
Cleared 510(K)
K
04
1131
APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
2
Cleared 510(K)
K
04
0244
MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
2
Cleared 510(K)
K
03
3644
ENDOBOY
2
Cleared 510(K)
K
03
3249
PAJUNK MODULAR HANDLE INSTRUMENTS
2
Cleared 510(K)
K
03
3842
NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
2
Cleared 510(K)
K
03
3359
DEGALL II GALLBLADDER EXTRACTOR
2
Cleared 510(K)
K
03
2676
ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR
2
Cleared 510(K)
K
03
2093
PARIEFIX
2
Cleared 510(K)
K
03
2889
OPTICAL SEPARATOR
2
Cleared 510(K)
K
03
2680
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
2
Cleared 510(K)
K
03
1593
SOPRO 61D
2
Cleared 510(K)
K
03
1882
ENDOSCOPIC APPLICATOR
2
Cleared 510(K)
K
03
2339
CARDIOVATIONS PORTABLE VIDEO SYSTEM
2
Cleared 510(K)
K
02
3735
LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
2
Cleared 510(K)
K
03
1891
VIRTUOSAPH
2
Cleared 510(K)
K
03
1847
CARDIOVATIONS RETRACTOR
2
Cleared 510(K)
K
03
1956
MODIFICATION TO HERMES O.R. CONTROL CENTER
2
Cleared 510(K)
K
03
1720
MODIFICATION TO HERMES O.R. CONTROL CENTER
2
Cleared 510(K)
K
03
1382
MODIFICATION TO HERMES O.R. CONTROL CENTER
2
Cleared 510(K)
K
03
0174
GENICON LAPAROSCOPES
2
Cleared 510(K)
K
03
0718
SCB COMPUTER MOTION INTERFACE CONTROLLER
2
Cleared 510(K)
K
02
2393
MERDOC SYSTEM
2
Cleared 510(K)
K
03
1098
3-CCD DIGITAL CAMERA SYSTEM
2
Cleared 510(K)
K
03
0824
LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
2
Cleared 510(K)
K
03
1379
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
2
Cleared 510(K)
K
03
0512
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
2
Cleared 510(K)
K
03
0422
LINA-BAG, MODELS LB-60, LB-100
2
Cleared 510(K)
K
03
0940
NOMAD ND1000M AUGMENTED VISION SYSTEM
2
Cleared 510(K)
K
02
4251
SIGHTFIX
2
Cleared 510(K)
K
03
0240
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
02
3630
ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
2
Cleared 510(K)
K
02
4294
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
02
3261
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
2
Cleared 510(K)
K
02
3095
HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
02
3629
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
2
Cleared 510(K)
K
02
3627
ESSEX ENDOSCOPE, MODEL SXD-1000
2
Cleared 510(K)
K
02
2897
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
02
3053
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
2
Cleared 510(K)
K
02
1731
ADAPT OPEN ACCESS PORT, MODEL 41233
2
Cleared 510(K)
K
02
1456
ER150/M2
2
Cleared 510(K)
K
02
1290
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
2
Cleared 510(K)
K
02
0915
SOPRO LIGHT SOURCES AND ACCESSORIES
2
Cleared 510(K)
K
02
0307
LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
2
Cleared 510(K)
K
01
3551
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM
2
Cleared 510(K)
K
02
0310
DAVLITE MICROENDOSCOPE & ACCESSORIES
2
Cleared 510(K)
K
02
0336
ENDOSCOPIC CAMERA MC404/C3
2
Cleared 510(K)
K
02
0270
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA
2
Cleared 510(K)
K
01
4158
ENDOSCOPIC CAMERA TC804/C4
2
Cleared 510(K)
K
02
0428
ENDOPATH DILATING TIP TROCAR, MODEL #512XD
2
Cleared 510(K)
K
01
4047
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
2
Cleared 510(K)
K
01
3952
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
2
Cleared 510(K)
K
01
4005
APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
2
Cleared 510(K)
K
01
3872
RUSCH MEMORY BAG
2
Cleared 510(K)
K
01
3701
ENDO-GLIDE
2
Cleared 510(K)
K
01
3611
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
2
Cleared 510(K)
K
01
3617
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
2
Cleared 510(K)
K
01
3576
PERICSCOPE, MODEL # PERISC1
2
Cleared 510(K)
K
01
3165
USA SERIES LAPAROSCOPES
2
Cleared 510(K)
K
01
2884
DILATING TIP OBTURATOR
2
Cleared 510(K)
K
01
4250
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
2
Cleared 510(K)
K
01
0033
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107
2
Cleared 510(K)
K
01
3695
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
2
Cleared 510(K)
K
01
3090
SOPRO 67D OPERATING ROOM CAMERA
2
Cleared 510(K)
K
01
2968
APPLIED ACCESS SEAL
2
Cleared 510(K)
K
01
2771
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
2
Cleared 510(K)
K
01
2527
KSEA SIALOENDOSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
00
3431
ZEUS ROBOTIC SURGICAL SYSTEM
2
Cleared 510(K)
K
01
2150
PATTON ENDO-BAG
2
Cleared 510(K)
K
01
1944
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
2
Cleared 510(K)
K
01
1841
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
2
Cleared 510(K)
K
01
2539
VERASTEP
2
Cleared 510(K)
K
01
0754
NURSE'S ASSISTANT O.R. CONTROL SYSTEM
2
Cleared 510(K)
K
01
1538
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
2
Cleared 510(K)
K
01
1501
ENDOPOUCH RETRIEVER
2
Cleared 510(K)
K
01
1360
MTP LAPAROMAT DISPOSABLE TUBING SET
2
Cleared 510(K)
K
01
1189
VIADUCT MICROENDOSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
01
1257
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
2
Cleared 510(K)
K
01
1997
MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX
2
Cleared 510(K)
K
01
1359
MODIFICATION TO KSEA ENDOTIP SYSTEM
2
Cleared 510(K)
K
01
0870
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
2
Cleared 510(K)
K
01
1183
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
2
Cleared 510(K)
K
00
3871
LAPAROSCOPIC HAND PORT
2
Cleared 510(K)
K
01
0620
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
2
Cleared 510(K)
K
01
0519
MAGNUM FLOW IRRIGATION SYSTEM
2
Cleared 510(K)
K
01
0346
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
2
Cleared 510(K)
K
01
1016
LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
2
Cleared 510(K)
K
01
0789
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
2
Cleared 510(K)
K
01
0489
DYONICS VISION 111 MOBILE VIDEO UNIT
2
Cleared 510(K)
K
01
0569
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP
2
Cleared 510(K)
K
01
0220
XTRACTOR, MODEL M143
2
Cleared 510(K)
K
00
3803
GENERAL SURGICAL LAPAROSCOPES
2
Cleared 510(K)
K
01
0007
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
2
Cleared 510(K)
K
00
3790
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
2
Cleared 510(K)
K
00
3217
HERMES PORT EXPANDER
2
Cleared 510(K)
K
00
2924
3D ENDOSCOPE
2
Cleared 510(K)
K
00
2431
ELRAN 01 SYSTEM
2
Cleared 510(K)
K
00
2542
REUSABLE CANNULA
2
Cleared 510(K)
K
00
2013
OMNIPORT
2
Cleared 510(K)
K
00
1666
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
2
Cleared 510(K)
K
99
2182
CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
2
Cleared 510(K)
K
00
1594
3.5 MM LAPAROSCOPE (LG100, LG103)
2
Cleared 510(K)
K
00
1597
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
2
Cleared 510(K)
K
00
0769
KSEA MANHES PNEUMOTROCAR
2
Cleared 510(K)
K
00
1264
EAGLE ENDO SPECIMEN RETRIEVAL BAG
2
Cleared 510(K)
K
00
0669
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
2
Cleared 510(K)
K
00
1169
OPTIVU HDVD SYSTEM
2
Cleared 510(K)
K
00
0493
STRYKER IRRIGATION TUBE SET
2
Cleared 510(K)
K
00
0663
KRONNER LOW PROFILE SCOPE HOLDER
2
Cleared 510(K)
K
00
0545
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
2
Cleared 510(K)
K
00
0337
MTP DISPOSABLE TROCAR VALVES
2
Cleared 510(K)
K
00
0424
S51D DIGITAL ENDOSCOPY CAMERA
2
Cleared 510(K)
K
00
0423
S52D DIGITAL VIDEO LAPAROSCOPE
2
Cleared 510(K)
K
00
0422
S57D DIGITAL OPERATING ROOM CAMERA
2
Cleared 510(K)
K
00
0202
CORTEK LAPAROSCOPES
2
Cleared 510(K)
K
99
4256
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
2
Cleared 510(K)
K
99
4066
MTP DISPOSABLE TROCARS
2
Cleared 510(K)
K
99
3688
AED LAPAROSCOPE
2
Cleared 510(K)
K
99
2852
SUTURE CLINCH
2
Cleared 510(K)
K
99
3045
BARIATRIC LAPAROSCOPE, MODEL 367
2
Cleared 510(K)
K
99
2612
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232
2
Cleared 510(K)
K
99
2250
CORE AUDIBLE TROCAR II
2
Cleared 510(K)
K
99
2437
SCHOELLY RIGID ENDOSCOPES
2
Cleared 510(K)
K
99
2190
CORE POUCH
2
Cleared 510(K)
K
99
0785
TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
99
2541
LAPAROCAM
2
Cleared 510(K)
K
99
2324
FUNNEL TROCAR
2
Cleared 510(K)
K
99
0724
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
2
Cleared 510(K)
K
99
1718
OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D
2
Cleared 510(K)
K
99
2353
BLUNT TIP TROCAR PORT
2
Cleared 510(K)
K
99
2288
AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
2
Cleared 510(K)
K
99
1416
ENDOSCOPIC CAMERA
2
Cleared 510(K)
K
99
1382
SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
2
Cleared 510(K)
K
99
1377
OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER
2
Cleared 510(K)
K
99
1303
VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
2
Cleared 510(K)
K
99
0237
TROCAR SYSTEM ACCORDING TO HASSON
2
Cleared 510(K)
K
99
1928
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
2
Cleared 510(K)
K
99
1444
HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).
2
Cleared 510(K)
K
99
1228
DCI ENDOSCOPE
2
Cleared 510(K)
K
99
1171
DCI ENDOSCOPE
2
Cleared 510(K)
K
99
1734
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
99
0912
MTP EXTRACTION BAG
2
Cleared 510(K)
K
98
4600
METRA PS PROCEDURE KIT
2
Cleared 510(K)
K
99
1703
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
2
Cleared 510(K)
K
99
1635
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
99
0663
INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150
2
Cleared 510(K)
K
99
0894
ETB TROCAR SYSTEM
2
Cleared 510(K)
K
99
0731
EASTGATE PERSONAL MONITOR
2
Cleared 510(K)
K
99
0635
VISTA STEREOSCOPE SYSTEM
2
Cleared 510(K)
K
99
0493
INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE
2
Cleared 510(K)
K
99
0414
SMITH & NEPHEW HANDPORT SYSTEM
2
Cleared 510(K)
K
99
0188
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
2
Cleared 510(K)
K
99
0028
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
2
Cleared 510(K)
K
98
4355
POINT SETTER
2
Cleared 510(K)
K
99
0691
HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
98
4434
MEDIVISION LAPAROSCOPE
2
Cleared 510(K)
K
99
0379
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
2
Cleared 510(K)
K
98
3527
MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE
2
Cleared 510(K)
K
98
3566
3-CHIP VIDEO CAMERA
2
Cleared 510(K)
K
98
3567
IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM
2
Cleared 510(K)
K
98
3623
MODULAP
2
Cleared 510(K)
K
98
3363
DCI ENDOSCOPE
2
Cleared 510(K)
K
98
3561
FUJINON EVL-F VIDEO LAPROSCOPE
2
Cleared 510(K)
K
98
3293
AUTO SUTURE LAPAROSCOPES DEVICE
2
Cleared 510(K)
K
98
3279
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
2
Cleared 510(K)
K
98
3538
MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
2
Cleared 510(K)
K
98
0129
INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS)
2
Cleared 510(K)
K
98
2013
MGB LAPALUX TELESCOPE
2
Cleared 510(K)
K
98
2417
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
2
Cleared 510(K)
K
98
2623
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
2
Cleared 510(K)
K
98
1940
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES
2
Cleared 510(K)
K
98
2073
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM
2
Cleared 510(K)
K
98
2445
MODULAP
2
Cleared 510(K)
K
98
1999
ALBATECH PERSONAL MONITOR
2
Cleared 510(K)
K
97
3943
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER
2
Cleared 510(K)
K
98
2287
ASLAN SENSOR MODULAR INSTRUMENT
2
Cleared 510(K)
K
98
1928
GALILEO DISPOSABLE ENDOSCOPES
2
Cleared 510(K)
K
98
1941
MULTAPORT CANNULA REDUCER AND ACCESSORIES
2
Cleared 510(K)
K
97
3430
KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
2
Cleared 510(K)
K
98
1531
SUTURE PLACEMENT DEVICE AND ACCESSORIES
2
Cleared 510(K)
K
98
0787
HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR
2
Cleared 510(K)
K
98
1598
HERNIA MESH STABILIZER
2
Cleared 510(K)
K
98
1700
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
2
Cleared 510(K)
K
97
4771
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
2
Cleared 510(K)
K
98
0604
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
98
0623
N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
2
Cleared 510(K)
K
98
0350
VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150
2
Cleared 510(K)
K
98
0279
SONY DXC-LS1 COLOR VIDEO CAMERA
2
Cleared 510(K)
K
97
4382
ACKERMANN SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
98
0599
NTECH ARTHROSCOPE
2
Cleared 510(K)
K
98
0079
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
2
Cleared 510(K)
K
97
3698
SCION BALLOON ELEVATOR
2
Cleared 510(K)
K
98
0023
ENDOPATH AND PROXIMATE LINEAR CUTTERS
2
Cleared 510(K)
K
98
0123
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
2
Cleared 510(K)
K
98
0022
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
2
Cleared 510(K)
K
98
0050
MENTOR SKIN PROTECTION PAD
2
Cleared 510(K)
K
97
3909
KSEA ENDOTIP SYSTEM
2
Cleared 510(K)
K
97
3700
HERMES OPERATING ROOM CONTROL CENTER
2
Cleared 510(K)
K
97
4336
CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
2
Cleared 510(K)
K
97
4391
KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM
2
Cleared 510(K)
K
97
3814
TRUMP-IT II AND MAGNUM 250
2
Cleared 510(K)
K
97
2298
ETB TELESCOPE W/WORKING CHANNEL FOR SEPS
2
Cleared 510(K)
K
97
4139
LQUET CANNULA/TROCAR SYSTEM
2
Cleared 510(K)
K
97
4767
SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES
2
Cleared 510(K)
K
97
3046
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK
2
Cleared 510(K)
K
97
4592
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
97
3543
KRONNER LOW PROFILE SCOPE HOLDER
2
Cleared 510(K)
K
97
0888
IOTEC TROCAR AND FLEXIBLE CANNULA
2
Cleared 510(K)
K
97
4366
KSEA PLASTIC TROCARS
2
Cleared 510(K)
K
97
3796
S-41 &41S VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
97
3794
S-57 VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
97
3795
S-52 ELECTRONIC VIDEO LAPAROSCOPE
2
Cleared 510(K)
K
97
2699
AESOP 3000 SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
97
2280
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
2
Cleared 510(K)
K
97
3436
VISTA HEAD MOUNTED DISPLAY
2
Cleared 510(K)
K
97
3415
CURVILINEAR SUTURE PLACEMENT SYSTEM
2
Cleared 510(K)
K
97
3249
ENDOASSIST
2
Cleared 510(K)
K
97
3359
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
2
Cleared 510(K)
K
97
3232
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
2
Cleared 510(K)
K
97
3139
ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR
2
Cleared 510(K)
K
97
3068
KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
2
Cleared 510(K)
K
97
2927
ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR
2
Cleared 510(K)
K
97
2984
LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE
2
Cleared 510(K)
K
97
2471
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES
2
Cleared 510(K)
K
97
2685
ORIGIN LIGATOR DEVICE
2
Cleared 510(K)
K
97
2578
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
2
Cleared 510(K)
K
97
0937
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
2
Cleared 510(K)
K
97
1150
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
2
Cleared 510(K)
K
97
2958
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS
2
Cleared 510(K)
K
97
2679
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
2
Cleared 510(K)
K
97
2178
UNISURGE INTERFACE P
2
Cleared 510(K)
K
97
1475
SHIELDED SURGICAL TROCAR
2
Cleared 510(K)
K
97
1850
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
97
2504
MVM 3.3 MM MICROENDOSCOPE
2
Cleared 510(K)
K
97
1738
ENDOPATH RESPOSABLE TROCAR SYSTEM
2
Cleared 510(K)
K
96
5001
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
2
Cleared 510(K)
K
97
2056
STANDARD ENDOSCOPE
2
Cleared 510(K)
K
97
1334
PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
2
Cleared 510(K)
K
97
0917
SOLOS 10MM OPERATING LAPAROSCOPE
2
Cleared 510(K)
K
97
0900
INSTRUMENT HOLDER
2
Cleared 510(K)
K
97
0605
3-CCD DIGITAL CAMERA
2
Cleared 510(K)
K
97
0949
SMITH & NEPHEW MIS INSTRUMENTS
2
Cleared 510(K)
K
97
0754
INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
2
Cleared 510(K)
K
97
0369
VISTA MINI CAMERA SYSTEM
2
Cleared 510(K)
K
97
0214
3 DIMENSIONAL VIDEO ENDOSCOPE
2
Cleared 510(K)
K
96
3126
AESOP SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
96
1343
MEDVISION PERSONAL MONITOR
2
Cleared 510(K)
K
96
4930
STRYKER SAPHENOUS VEIN HARVEST SCOPE
2
Cleared 510(K)
K
96
2702
SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA
2
Cleared 510(K)
K
96
4171
VASOVIEW BALLOON DISSECTION SYSTEM
2
Cleared 510(K)
K
96
3115
TROCAR CANNULA
2
Cleared 510(K)
K
97
0054
TANDEMRX
2
Cleared 510(K)
K
96
4672
SUTURE APPLICATOR
2
Cleared 510(K)
K
97
0056
SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
2
Cleared 510(K)
K
96
4258
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781
2
Cleared 510(K)
K
96
3919
LSI VIDEOSCOPIC DISPLAY SYSTEM
2
Cleared 510(K)
K
96
3760
NON-SHIELDED SURGICAL TROCAR AND SLEEVE
2
Cleared 510(K)
K
96
3184
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
96
4123
REUSABLE TROCAR WITH SLEEVE (COMMON)
2
Cleared 510(K)
K
96
4334
EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
2
Cleared 510(K)
K
96
3323
ENDO VIP
2
Cleared 510(K)
K
96
3815
REUSABLE TROCAR WITH SLEEVE (COMMON)
2
Cleared 510(K)
K
96
3046
ENDOCAM
2
Cleared 510(K)
K
96
3329
ETHICON ENDOSUTURE SYSTEM
2
Cleared 510(K)
K
96
2684
S-357 VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
96
2799
MINIATURE LAPAROSCOPE SET (MINI LAP)
2
Cleared 510(K)
K
96
1463
HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2
2
Cleared 510(K)
K
96
2651
S-52 ELECTRONIC VIDEO LAPAROSCOPE
2
Cleared 510(K)
K
96
0301
ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR
2
Cleared 510(K)
K
96
2104
AIRLIFT BALLOON RETRACTON SYSTEM
2
Cleared 510(K)
K
96
1800
HEAD MOUNTED DISPLAY
2
Cleared 510(K)
K
96
2020
S-41 & S-41S VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
96
2193
PORTLAND TROCARS
2
Cleared 510(K)
K
96
0903
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
2
Cleared 510(K)
K
96
2005
EXTRAHAND BALLOON RETRACTOR
2
Cleared 510(K)
K
96
1182
3D SCOPE
2
Cleared 510(K)
K
96
1940
INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
2
Cleared 510(K)
K
96
2147
DEXTERITY PNEUMO SLEEVE SET
2
Cleared 510(K)
K
96
2395
SPECIMEN RETRIEVAL BAG
2
Cleared 510(K)
K
95
5845
LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
2
Cleared 510(K)
K
96
0637
5MM ENDOSCOPE
2
Cleared 510(K)
K
96
1430
INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP
2
Cleared 510(K)
K
96
1224
HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM
2
Cleared 510(K)
K
96
1492
HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010
2
Cleared 510(K)
K
96
0655
AESOP SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
96
0562
GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005
2
Cleared 510(K)
K
96
1175
TROGARD TROCAR DIALATING TROCAR SYSTEM
2
Cleared 510(K)
K
96
0748
MODIFIED HAND INSTRUMENT DEVICES
2
Cleared 510(K)
K
95
5076
SAFE TEE
2
Cleared 510(K)
K
96
0232
ENDOSCOPIC ACCESS DEVICE
2
Cleared 510(K)
K
96
0883
INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8
2
Cleared 510(K)
K
96
0878
MAHLER ABDOMINAL WALL ELEVATOR
2
Cleared 510(K)
K
95
4864
ASLAN MODULAR INSTRUMENT
2
Cleared 510(K)
K
95
3419
LOS 3D VISION 100
2
Cleared 510(K)
K
95
5404
OTV-S5 OES VIDEO SYSTEM
2
Cleared 510(K)
K
95
5408
MICROSURGE THORACOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
95
5490
LAPAROSCOPIC KNITTER
2
Cleared 510(K)
K
95
2959
THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK
2
Cleared 510(K)
K
95
2906
THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK
2
Cleared 510(K)
K
95
4649
WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP
2
Cleared 510(K)
K
95
4853
AUTO SUTURE SUTURE CLOSURE
2
Cleared 510(K)
K
94
3307
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
2
Cleared 510(K)
K
95
4160
MSV-2000 VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
95
2953
THE TULIP CXOMPANY BRANSON #2 ELEVATOR
2
Cleared 510(K)
K
95
2932
THE TULIP COMPANY BRANSON #1 ELEVATOR
2
Cleared 510(K)
K
95
2958
THE TULIP COMPANY BRANSON OVERSHEATH
2
Cleared 510(K)
K
95
2951
THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR
2
Cleared 510(K)
K
95
2902
THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR
2
Cleared 510(K)
K
95
2901
THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR
2
Cleared 510(K)
K
95
4175
DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]
2
Cleared 510(K)
K
95
4174
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]
2
Cleared 510(K)
K
95
3438
SURGICAL INTEGRATED CAMERA SYSTEM
2
Cleared 510(K)
K
95
4089
ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE
2
Cleared 510(K)
K
95
2956
THE TULIP COMPANY BRANSON DOUBLE-ENDED DISSECTOR
2
Cleared 510(K)
K
95
2934
THE TULIP COMPANY BRANSON RECURVED DISSECTOR
2
Cleared 510(K)
K
95
2936
THE TULIP COMPANY BRANSON ANTERIOR ELEVATOR
2
Cleared 510(K)
K
95
2954
THE TULIP COMPANY WEIL-BLAKESLEY FORCEPS
2
Cleared 510(K)
K
95
2955
THE TULIP COMPANY BRANSON STRAIGHT DISSECTOR
2
Cleared 510(K)
K
95
2957
THE TULIP INSULATED GRASPERS
2
Cleared 510(K)
K
95
2900
THE TULIP COMPANY BRANSON SOFT TISSUE RETRACTOR
2
Cleared 510(K)
K
95
2899
THE TULIP INSULATED SCISSORS
2
Cleared 510(K)
K
95
4072
MICROSURGE PUNCTURE CLOSE DEVICE
2
Cleared 510(K)
K
95
3377
DISTENTION BALLOON
2
Cleared 510(K)
K
95
3903
LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM
2
Cleared 510(K)
K
95
4108
MODIFIED VERSAPORT
2
Cleared 510(K)
K
95
3409
LAPAROSCOPIC TROCAR
2
Cleared 510(K)
K
95
3418
ELECTROCAUTERY SHROUD
2
Cleared 510(K)
K
95
1646
3DSEE
2
Cleared 510(K)
K
95
3410
BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR
2
Cleared 510(K)
K
95
3121
MICROSURGE THORACOSCOPIC ACCESS SYSTEM
2
Cleared 510(K)
K
95
2980
THE TULIP LARGE SOFT TISSUE RETRACTOR
2
Cleared 510(K)
K
95
2935
THE TULIP SMALL SOFT TISSUE RETRACTOR
2
Cleared 510(K)
K
95
3086
WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA
2
Cleared 510(K)
K
95
2965
THE TULIP J DISSECTOR
2
Cleared 510(K)
K
95
3611
DEXIDE ENDO-LUBE KIT
2
Cleared 510(K)
K
95
1482
ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)
2
Cleared 510(K)
K
95
3376
ACCESS POINT
2
Cleared 510(K)
K
95
3348
ARTICULATING RETRACTOR TISSUE RETRACTORS
2
Cleared 510(K)
K
95
4011
FASCIA CLOSURE DEVICE
2
Cleared 510(K)
K
95
3123
QUIK-STITCH
2
Cleared 510(K)
K
95
1990
LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE
2
Cleared 510(K)
K
95
1996
IMAGYN ENDOSCOPE
2
Cleared 510(K)
K
95
3440
ELLMAN LAPTRODE
2
Cleared 510(K)
K
95
3243
LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH
2
Cleared 510(K)
K
95
1974
IMAGYN ENDOSCOPE SHEATH
2
Cleared 510(K)
K
95
3549
KSEA EXTRACTION BAG
2
Cleared 510(K)
K
95
3509
BIPOLAR COAGULATING FORCEPS
2
Cleared 510(K)
K
95
3481
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER
2
Cleared 510(K)
K
95
3561
PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)
2
Cleared 510(K)
K
95
2443
KARL STORZ ENDOSCOPY POWDER BLOWER
2
Cleared 510(K)
K
95
2444
SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA
2
Cleared 510(K)
K
95
2278
THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA
2
Cleared 510(K)
K
95
2926
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
2
Cleared 510(K)
K
95
2842
ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE
2
Cleared 510(K)
K
95
2785
BRIMFIELD PRECISION DETACHABLE SCISSOR
2
Cleared 510(K)
K
94
2910
DEEPVISON
2
Cleared 510(K)
K
95
2977
SABRE MULTI-USE TROCAR SYSTEM
2
Cleared 510(K)
K
95
2814
ETHICON ARTHROSCOPIC KNOT PUSHER
2
Cleared 510(K)
K
95
2723
DEVMED REUSEABLE TROCAR SYSTEM
2
Cleared 510(K)
K
95
1090
INTRODUCER
2
Cleared 510(K)
K
95
1386
COMBINATION CAMERA/LIGHT SOURCE
2
Cleared 510(K)
K
95
1878
SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
2
Cleared 510(K)
K
95
1546
ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS
2
Cleared 510(K)
K
93
2033
LAPAROSCOPIC SURGERY INSTRUMENTS
2
Cleared 510(K)
K
95
1522
WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA
2
Cleared 510(K)
K
95
2264
ASLAN LAPRETRACT
2
Cleared 510(K)
K
95
1986
INSULATED ELECTROSURGICAL INSTRUMENTS
2
Cleared 510(K)
K
95
2421
NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS
2
Cleared 510(K)
K
95
1733
NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS
2
Cleared 510(K)
K
95
0702
LAPAROSCOPIC CLAMP
2
Cleared 510(K)
K
95
0862
KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES
2
Cleared 510(K)
K
95
1625
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
2
Cleared 510(K)
K
95
0753
CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO
2
Cleared 510(K)
K
95
1715
ENDO IRRIGATOR 2211, INCLUDING TUBING
2
Cleared 510(K)
K
95
0658
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:
2
Cleared 510(K)
K
95
0632
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
2
Cleared 510(K)
K
95
1535
KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS
2
Cleared 510(K)
K
95
0959
TROCAR SUPRAPUBIC, NON-DISPOSABLE TROCAR, DISPOSABLE
2
Cleared 510(K)
K
95
0562
IMPLANTABLE STAPLE
2
Cleared 510(K)
K
95
0502
CCD ENDOCAM 5501
2
Cleared 510(K)
K
95
1692
MIST ENDOSCOPIC PROBES
2
Cleared 510(K)
K
95
1481
MIST ENDOSCOPIC CANNULAS
2
Cleared 510(K)
K
95
1480
MIST TROCARS
2
Cleared 510(K)
K
95
1398
MIST REDUCER SLEEVES
2
Cleared 510(K)
K
95
1444
ENDOPATH OPTICAL ACCESS NEEDKLE
2
Cleared 510(K)
K
95
1252
KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME
2
Cleared 510(K)
K
95
0612
ENDOSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
95
0726
TSI WILLEN-REICH NEEDLE
2
Cleared 510(K)
K
95
0126
ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE
2
Cleared 510(K)
K
95
1387
SYMBIOSIS BIPOLAR SCISSORS
2
Cleared 510(K)
K
95
0339
KSEA STEINER ELECTROMECHANIC MORCELLATOR
2
Cleared 510(K)
K
95
0243
TITAN INSUFFLATION NEEDLE
2
Cleared 510(K)
K
95
1251
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
2
Cleared 510(K)
K
94
4309
M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM
2
Cleared 510(K)
K
95
0021
REUSABLE TROCAR WITH SAFETY SLEEVE
2
Cleared 510(K)
K
95
0985
ZEISS ENDOLIVE STERO ENDOSCOPE
2
Cleared 510(K)
K
95
0277
INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER
2
Cleared 510(K)
K
95
0811
KARL STORZ FIBER OPTIC LIGH CABLES
2
Cleared 510(K)
K
95
1173
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
2
Cleared 510(K)
K
95
1082
CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE
2
Cleared 510(K)
K
95
1086
NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
95
1060
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRN
2
Cleared 510(K)
K
95
0744
CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)
2
Cleared 510(K)
K
95
0746
CHAKOFF ENDOSCOPY (SET LAPAROSCOPY)
2
Cleared 510(K)
K
95
0748
CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE)
2
Cleared 510(K)
K
95
0745
CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES)
2
Cleared 510(K)
K
95
0747
CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)
2
Cleared 510(K)
K
95
0103
LAPAROSCOPE, HAND INSTRUMENTS
2
Cleared 510(K)
K
94
6089
NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA
2
Cleared 510(K)
K
95
0297
ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM
2
Cleared 510(K)
K
95
0076
LAPAROSCOPE
2
Cleared 510(K)
K
94
5953
GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)
2
Cleared 510(K)
K
94
3554
DOFI RASTER-SCREEN
2
Cleared 510(K)
K
95
0503
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
2
Cleared 510(K)
K
95
0500
BASIC REUSABLE TROCAR SYSTEM
2
Cleared 510(K)
K
94
5862
ENDCUP
2
Cleared 510(K)
K
94
5266
OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
2
Cleared 510(K)
K
94
5890
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KARL STORZ KNOT TIER
2
Cleared 510(K)
K
95
0336
KARL STORZ ADAPTERS FOR DOCUMENTATION PURPOSES
2
Cleared 510(K)
K
95
0378
ARGUS LAPAROSCOPY INSTRUMENT SYSTEM
2
Cleared 510(K)
K
95
0198
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
2
Cleared 510(K)
K
95
0214
ABDOMINAL WALL RETRACTOR
2
Cleared 510(K)
K
94
6330
KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR
2
Cleared 510(K)
K
95
0286
SYMBIOSIS BIPOLAR SCISSORS
2
Cleared 510(K)
K
95
0278
MINI LAPAROSCOPY FOR GENERAL SURGERY
2
Cleared 510(K)
K
95
0170
CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE
2
Cleared 510(K)
K
95
0231
LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERY
2
Cleared 510(K)
K
94
6239
ENDOXFLEX 5000
2
Cleared 510(K)
K
95
0063
WGL ENDOSCOPIC GRASPER*
2
Cleared 510(K)
K
94
6241
ENDOPATH(R) TRISTAR(TM) DISSECTOR AND TISSUE MANIPULATOR
2
Cleared 510(K)
K
94
6213
KSEA STEINER ELECTROMECHANIC MORCELLATORT
2
Cleared 510(K)
K
94
5520
HEMOCLIP ECOSYSTEM
2
Cleared 510(K)
K
94
5394
INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER
2
Cleared 510(K)
K
94
6263
BRIMFIELD PRECISION GRASPER/DISSECTOR
2
Cleared 510(K)
K
94
6171
VIDEO ENDOSCOPE SYSTEM WITH ZOOM
2
Cleared 510(K)
K
95
0005
TROCAR CANNULA STABILIZER
2
Cleared 510(K)
K
94
6164
KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS
2
Cleared 510(K)
K
94
5170
QUIK-STITCH
2
Cleared 510(K)
K
94
1222
OPEN LAPAROSCOPY TROCAR CONE SYSTEM
2
Cleared 510(K)
K
94
5545
ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
94
3614
A.W.E.L.
2
Cleared 510(K)
K
94
2601
PSI FLEXIBLE ARM
2
Cleared 510(K)
K
94
5979
TROCAR/CANNULA
2
Cleared 510(K)
K
94
6023
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
2
Cleared 510(K)
K
94
5297
INFRA VISION IMAGING SYSTEM
2
Cleared 510(K)
K
94
5751
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES
2
Cleared 510(K)
K
94
5263
OPTUS THORACOSCOPES
2
Cleared 510(K)
K
94
2168
WGL ENDOSCOPIC GRASPER
2
Cleared 510(K)
K
94
4299
KARL STORZ INSULATED BIOPSY FORCEPS
2
Cleared 510(K)
K
94
5637
R-MED MOTORIZED LAPAROSCOPIC HANDLE
2
Cleared 510(K)
K
94
4672
INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES
2
Cleared 510(K)
K
94
5474
SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER
2
Cleared 510(K)
K
94
4303
COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANER
2
Cleared 510(K)
K
94
4201
HI-Q HAND INSTRUMENTS- UROLOGY
2
Cleared 510(K)
K
94
5457
TROCAR ( ACCESORY)
2
Cleared 510(K)
K
94
5369
LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE
2
Cleared 510(K)
K
94
1348
KRONNER LAPAROSCOPIC HOLDER
2
Cleared 510(K)
K
94
5101
KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD
2
Cleared 510(K)
K
94
5059
KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS
2
Cleared 510(K)
K
94
4974
ACCESS POINT
2
Cleared 510(K)
K
94
4954
ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
94
0960
SUCTION AND IRRIGATION TUBES
2
Cleared 510(K)
K
94
3435
CHOLANGIOGRAPHY SET
2
Cleared 510(K)
K
94
3327
CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS
2
Cleared 510(K)
K
94
5023
ORIGIN PIXIE STIC INTRODUCER SLEEVE
2
Cleared 510(K)
K
94
0790
BABCOCK/BOWEL CLAMP FORCEPS
2
Cleared 510(K)
K
94
4870
JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680
2
Cleared 510(K)
K
94
4418
THE SPACEMAKER AND THE SPACEMAKER II
2
Cleared 510(K)
K
94
3253
INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
2
Cleared 510(K)
K
94
3502
UNIGRIP
2
Cleared 510(K)
K
94
4536
GSI KNOTMAKER
2
Cleared 510(K)
K
94
4467
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
94
2924
MSV-2000 VIDEO IMAGING SYSTEM
2
Cleared 510(K)
K
94
4465
CARRIER, LIGATURE (79 GEJ)
2
Cleared 510(K)
K
94
2574
GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
2
Cleared 510(K)
K
94
4414
DEKALB
2
Cleared 510(K)
K
94
3056
SINGLE STICK RADIALLY EXPANDING DILATOR
2
Cleared 510(K)
K
94
4304
ORIGIN BALLOON ANCHOR
2
Cleared 510(K)
K
94
2306
IRRIGATION/ASPIRATION INSTRUMENT
2
Cleared 510(K)
K
94
4224
KARL STORZ FLUID LIGHT CABLES
2
Cleared 510(K)
K
94
3927
END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM
2
Cleared 510(K)
K
93
5277
KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH
2
Cleared 510(K)
K
94
3786
PORTLAND TROCARS
2
Cleared 510(K)
K
94
4082
ASLAN DUAL ACTION JAWS GRASPING FORCEPS
2
Cleared 510(K)
K
94
0731
INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES
2
Cleared 510(K)
K
94
4103
LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
2
Cleared 510(K)
K
93
5279
KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE
2
Cleared 510(K)
K
94
3958
MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
94
3976
SABRE ULTIMATE SHIELDED TROCAR
2
Cleared 510(K)
K
94
0427
KARL STORZ THORACIC SURGERY INSTRUMENTS
2
Cleared 510(K)
K
94
3970
DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE
2
Cleared 510(K)
K
93
4704
AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH
2
Cleared 510(K)
K
93
5270
MODULAR FORCEP AND SCISSOR SYSTEM
2
Cleared 510(K)
K
94
2817
CCD ENDOCAM OFFICE 5510
2
Cleared 510(K)
K
94
2819
TROCAR WITH SHIELD
2
Cleared 510(K)
K
94
2740
SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM
2
Cleared 510(K)
K
94
1027
ENDOPATH OPTICAL OBTURATOR AND SLEEVE
2
Cleared 510(K)
K
94
2703
GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA
2
Cleared 510(K)
K
94
1401
MILL ROSE ERCP CANNULAS
2
Cleared 510(K)
K
93
6195
LAPAROSCOPES
2
Cleared 510(K)
K
94
2612
KARL STORZ WOUND CLOSURE INSTRUMENTS
2
Cleared 510(K)
K
94
2597
CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR
2
Cleared 510(K)
K
94
1950
OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360
2
Cleared 510(K)
K
94
3671
GSI CANNULA REDUCER ACCESSORY
2
Cleared 510(K)
K
94
3489
DISPOSABLE SURGICAL TROCAR
2
Cleared 510(K)
K
94
2358
AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA
2
Cleared 510(K)
K
94
3117
INTRA-SONIX UROFIBER
2
Cleared 510(K)
K
94
3172
CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR
2
Cleared 510(K)
K
94
2839
OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY
2
Cleared 510(K)
K
94
3070
REUSABLE PROBES
2
Cleared 510(K)
K
94
0948
ANGLED DISSECTORS MODELS 8383.581/582/571
2
Cleared 510(K)
K
93
5243
AESCULAP FLEXIBLE TROCAR INSTRUMENT SET
2
Cleared 510(K)
K
94
2879
DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
2
Cleared 510(K)
K
94
1773
MEDICAM 900 REMOTE
2
Cleared 510(K)
K
94
2678
LIFTING DISTENTION BALLOON SYSTEM
2
Cleared 510(K)
K
94
2641
SURGIN IRRIGATION PUMP
2
Cleared 510(K)
K
94
2491
ORIGIN BALLOON RETRACTOR
2
Cleared 510(K)
K
94
1249
SPECIMEN REMOVAL DEVICE
2
Cleared 510(K)
K
94
1747
SURGISTAR TROCARS
2
Cleared 510(K)
K
93
6262
DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS
2
Cleared 510(K)
K
93
0224
STRYKER ARTHROSCOPIC ACCESSORIES
2
Cleared 510(K)
K
94
1693
MEDICAM ENDOCOUPLER AND BEAMSPLITTER
2
Cleared 510(K)
K
94
2584
PUTMAN STABILIZER
2
Cleared 510(K)
K
94
2414
TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE
2
Cleared 510(K)
K
94
2415
R-BAR RETRACTOR
2
Cleared 510(K)
K
94
2053
AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET
2
Cleared 510(K)
K
94
0988
ACCESSORIES, SURGICAL CAMERA
2
Cleared 510(K)
K
93
3750
MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF
2
Cleared 510(K)
K
94
1390
DISPOSABLE ASPIRATION/IRRIGATION TRUMPET VALVE PROBE
2
Cleared 510(K)
K
94
2416
HASSON GRASPERS
2
Cleared 510(K)
K
93
2626
CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB
2
Cleared 510(K)
K
93
3330
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
94
1136
KNOT SLIDE 8383.55 AND 8383.551
2
Cleared 510(K)
K
94
0347
TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
2
Cleared 510(K)
K
94
2202
SUCTION AND IRRIGATION TUBES
2
Cleared 510(K)
K
94
2201
LAPAROSCOPY DILATION SYSTEM
2
Cleared 510(K)
K
94
1286
SUTURE MANIPULATOR
2
Cleared 510(K)
K
94
0141
LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
2
Cleared 510(K)
K
93
5786
CORSON AND NEZHAT SUCTION/IRRIGATION PROBES
2
Cleared 510(K)
K
94
0011
MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM
2
Cleared 510(K)
K
93
5826
LAPAROSCOPIC/SUCTION/IRRIGATION PROBE
2
Cleared 510(K)
K
93
6102
DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES
2
Cleared 510(K)
K
94
1967
HSW LAPAROSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
94
1541
HSV LAPAROSCOPY SET
2
Cleared 510(K)
K
93
6248
MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS
2
Cleared 510(K)
K
93
6279
GALILEO ENDOSCOPES
2
Cleared 510(K)
K
93
0667
REUSABLE LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
94
0346
SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
2
Cleared 510(K)
K
93
6250
RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP
2
Cleared 510(K)
K
93
5986
GORE LAPAROSCOPIC SUTURE PASSER
2
Cleared 510(K)
K
93
3497
LAPAROSCOPIC COVERED SURGICAL RETRACTOR
2
Cleared 510(K)
K
93
2553
DISPOSABLE SUTURE PLACEMENT SYSTEM
2
Cleared 510(K)
K
94
1250
TROCAR AND CANNULA
2
Cleared 510(K)
K
93
4916
CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS
2
Cleared 510(K)
K
93
3458
SURGICAL TROCARS
2
Cleared 510(K)
K
94
0875
ADJUSTABLE BALLOON DISSECTION CANNULA
2
Cleared 510(K)
K
93
5754
MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER
2
Cleared 510(K)
K
94
1276
BRIMFIELD PRECISION SECOND GENERATION GRASPER/DISSECTOR
2
Cleared 510(K)
K
94
0551
ENDOSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
94
0431
TECNADYNE 20/20 FOG INHIBITOR KIT
2
Cleared 510(K)
K
92
4792
MULTIPLE PURPOSE FORCEPS
2
Cleared 510(K)
K
94
0891
TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER
2
Cleared 510(K)
K
94
0428
INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR
2
Cleared 510(K)
K
94
0157
ENLINE MONOPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
5071
INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS
2
Cleared 510(K)
K
93
2987
BIRTCHER LAPAROSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
93
0887
BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)
2
Cleared 510(K)
K
93
6114
BIRTCHER PERICARDIAL KNIVES
2
Cleared 510(K)
K
94
1316
BRIMFIELD PRECISION FAN RETRACTOR
2
Cleared 510(K)
K
93
5207
ENDOFLUSH SYSTEM 1.0, 2.O, 3.0
2
Cleared 510(K)
K
94
0900
APPENDIX EXTRACTOR 8385.50
2
Cleared 510(K)
K
94
1500
TISSUE ISOLATION AND RETRIEVAL BAG
2
Cleared 510(K)
K
93
3169
INMAN ENDOSCOPIC BLUNT DISSECTOR
2
Cleared 510(K)
K
94
0232
INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
2
Cleared 510(K)
K
94
1024
AESCULAP TROCAR COLLAR
2
Cleared 510(K)
K
94
0241
ACUFEX VIDEO SYSTEM
2
Cleared 510(K)
K
93
1778
LAPAROSCOPY INSTRUMENTS
2
Cleared 510(K)
K
94
1092
MURDOCH LAPAROSCOPE LENS CLEANER
2
Cleared 510(K)
K
93
0965
LOS 3D VISION 100
2
Cleared 510(K)
K
94
0398
AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II
2
Cleared 510(K)
K
93
1850
VERRSS PNEUMO NEEDLE
2
Cleared 510(K)
K
93
6097
VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL
2
Cleared 510(K)
K
93
0813
PISTOL SUCTION/IRRIGATION PROBE
2
Cleared 510(K)
K
94
0199
DISSECTOR
2
Cleared 510(K)
K
94
0155
ENLINE ENDOSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
2060
MARTIN COLD LIGHT FOUNTAIN
2
Cleared 510(K)
K
94
0587
FLEX-I-PORT
2
Cleared 510(K)
K
94
0439
GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT
2
Cleared 510(K)
K
93
1879
REFLEX HTR
2
Cleared 510(K)
K
93
0254
DAVIS+GECK REUSABLE TRTOCARS
2
Cleared 510(K)
K
92
5958
SCISSOR FOR LAPAROSCOPIC SURGERY GU USE
2
Cleared 510(K)
K
93
5604
LASERSONICS TISSUE MORCELLATOR SET
2
Cleared 510(K)
K
93
4937
KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC
2
Cleared 510(K)
K
93
5109
SDR (SOFT DISSECTOR RAKE)
2
Cleared 510(K)
K
94
0688
TROCAR TUBE
2
Cleared 510(K)
K
93
5234
STRYKER ENDOSCOPIC VIDEO ACCESSORIES
2
Cleared 510(K)
K
93
4155
WATTS RAKE WITH LEUR PORT & AQUA-PROBE TIP
2
Cleared 510(K)
K
93
4153
WATTS RAKE WITH LEUR LOCK PORT
2
Cleared 510(K)
K
94
0687
TROCAR
2
Cleared 510(K)
K
93
3776
OPTIK LAPAROSCOPE
2
Cleared 510(K)
K
93
5442
MAHE INSTRUMENTS
2
Cleared 510(K)
K
93
5115
EEC PROBE
2
Cleared 510(K)
K
93
4737
LASSO (SCHWAITZBERG) SUTURE SNARE
2
Cleared 510(K)
K
93
5645
FLOWGUN REUSABLE IRRIGATION PROBES
2
Cleared 510(K)
K
93
2617
S*E*M*M-SET & C*U*R*T-SET
2
Cleared 510(K)
K
93
2696
ISI(R) CURVED, TAPERED DISSECTING FORCEPS
2
Cleared 510(K)
K
93
2695
ISI(R) PORPOISE NOSE DISSECTING FORCEPS
2
Cleared 510(K)
K
93
4807
PUNCTURE CLOSURE DEVICE
2
Cleared 510(K)
K
93
0848
SENSING TIP SURGICAL TROCAR
2
Cleared 510(K)
K
92
6479
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
2
Cleared 510(K)
K
93
4527
FASCIA STITCHER
2
Cleared 510(K)
K
92
6080
DMI LAPAROSCOPIC IRRIGATION PUMP
2
Cleared 510(K)
K
93
3353
IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES
2
Cleared 510(K)
K
93
3345
NOBLES-LAI ENDOSCOPIC/LAPAROSCOPIC
2
Cleared 510(K)
K
93
1425
SURGICAL PATCH SPREADER
2
Cleared 510(K)
K
93
4547
MECTRA TROCAR
2
Cleared 510(K)
K
93
4094
STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
2
Cleared 510(K)
K
92
5499
LAPROSCOPIC/ENDOSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
94
0259
STERILE TROCAR AND 5.7MM SLEEVE
2
Cleared 510(K)
K
93
5086
AUTO SUTURE DISPOSABLE OPTICAL TROCAR
2
Cleared 510(K)
K
93
4750
YANKAUER WITH CONNECTING TUBING
2
Cleared 510(K)
K
93
4511
5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS
2
Cleared 510(K)
K
93
2540
LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE
2
Cleared 510(K)
K
93
4528
2C LENS FOG REDUCTION & CLEANING DEVICE
2
Cleared 510(K)
K
94
0193
SURGICAL RETRACTOR KIT
2
Cleared 510(K)
K
93
5382
GRASPERS
2
Cleared 510(K)
K
93
5293
FLUID ASPIRATION NEEDLE
2
Cleared 510(K)
K
93
0607
GRIPPER
2
Cleared 510(K)
K
93
4398
ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE
2
Cleared 510(K)
K
93
4338
INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
2
Cleared 510(K)
K
93
5878
GLASSER SUTURE NEEDLE
2
Cleared 510(K)
K
93
4097
I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
2
Cleared 510(K)
K
93
6154
LAPAROSCOPIC TROCAR STARTER SCALPEL
2
Cleared 510(K)
K
93
5999
DAVINCI RECONFIGURABLE LAPAROSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
2627
CHAKOFF ENDOSCOPY
2
Cleared 510(K)
K
93
3075
LAPAROSCOPIC RETRACTOR
2
Cleared 510(K)
K
93
1522
FASCIAL CLOSURE DEVICE
2
Cleared 510(K)
K
93
0180
BIOPSY CUP FORCEPS
2
Cleared 510(K)
K
93
2796
OWENS TROCAR
2
Cleared 510(K)
K
93
2441
SERIES 8920 TROCAR SYSTEM
2
Cleared 510(K)
K
93
5709
GENERAL SURGERY PROBE/GENERAL SURGERY PROBE W/DISTAL PERFORATIONS
2
Cleared 510(K)
K
93
5762
AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE
2
Cleared 510(K)
K
93
5073
NON-INSULATED SCISSORS
2
Cleared 510(K)
K
93
3067
PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS
2
Cleared 510(K)
K
93
5426
PREPERITONEAL DISTENTION BALLOON SYSTEM
2
Cleared 510(K)
K
93
4158
5MM CALIBRATED SUCTION CANNULA
2
Cleared 510(K)
K
93
4157
HYDRO-PROBE
2
Cleared 510(K)
K
93
4165
STERILE, DISPOSABLE ENDO SPECIEMEN RETRIEVAL BAG
2
Cleared 510(K)
K
93
4077
PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT DISSECTING INSTRUMENT
2
Cleared 510(K)
K
93
3725
ENDOSCOPIC NEEDLE DRIVER
2
Cleared 510(K)
K
93
3025
LAPORASCOPIC CANNULA SEAL
2
Cleared 510(K)
K
93
4347
ANTIFOG
2
Cleared 510(K)
K
93
4280
PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
2
Cleared 510(K)
K
93
4279
PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED TROCAR TUBES
2
Cleared 510(K)
K
93
2346
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
93
3790
5MM DISPOSABLE SUCTION-IRRIGATION CANNULA
2
Cleared 510(K)
K
93
3789
10MM DISPOSABLE, STERILE SUCTION CANNULA
2
Cleared 510(K)
K
93
3895
PHX TECHNOLOGIES CORP., GRASPER-RETRACTOR DEVICE
2
Cleared 510(K)
K
93
3724
SENSOR-TIP TROCAR
2
Cleared 510(K)
K
93
2692
INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT
2
Cleared 510(K)
K
93
4739
DAVINCI CHOLANGIOGRAM DELIVERY DEVICE
2
Cleared 510(K)
K
93
4163
WATTS RAKE DEVICE
2
Cleared 510(K)
K
93
3834
AESCULAP RIGID ENDOSCOPES
2
Cleared 510(K)
K
93
4078
PHX TECHNOLOGIES CORP.,10MM STERILE, DISPOSABLE POOL TIP SUCTION CANNULA
2
Cleared 510(K)
K
93
4027
PHX TECHNOLOGIES CORP., ALLIGATOR GRASPER DEVICE
2
Cleared 510(K)
K
93
4023
PHX TECHNOLOGIES CORP., ALTRAUMATIC GRASPER DEVICE
2
Cleared 510(K)
K
93
4022
PHX TECH SINGLE ACTION HEAVY-TOOTH JAW CLAW GRASPER
2
Cleared 510(K)
K
93
4021
PHX TECHNOLOGIES CORP., BOWEL GRASPER DEVICE
2
Cleared 510(K)
K
93
4024
PHX TECHNOLOGIES CORP., SUTURE GRASPER DEVICE
2
Cleared 510(K)
K
93
4025
PHX TECHNOLOGIES CORP, SPONGE GRASPER DEVICE
2
Cleared 510(K)
K
93
4026
PHX TECHNOLOGIES CORP. BOWEL GRASPER DEVICE
2
Cleared 510(K)
K
92
6181
ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY
2
Cleared 510(K)
K
93
4185
TROCAR REDUCER WITH GAS CLHECK VALVE
2
Cleared 510(K)
K
93
4098
STERILE, DISPOSABLE ENDOSCOPIC TRUMPET VALVE
2
Cleared 510(K)
K
93
3812
ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES
2
Cleared 510(K)
K
93
1962
NON-ABSORBABLE GAUZE
2
Cleared 510(K)
K
93
3897
PHX TECHNOLOGIES CORP., 5MM DISPOSABLE SUCTION-IRRIGATION CANNULA CLEANER
2
Cleared 510(K)
K
93
3896
PHX TECHNOLOGIES CORP., MONOPOLAR ELECTROCAUTERY PROBE TIP CLEANER
2
Cleared 510(K)
K
93
2321
LAPAROSCOPY OPTICS
2
Cleared 510(K)
K
93
4534
TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION
2
Cleared 510(K)
K
93
4173
SUTURE HANDLER
2
Cleared 510(K)
K
93
3536
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER
2
Cleared 510(K)
K
93
1783
AESOP (AUTOMATED ENDOSCOPIC SYSTEM FOR OPTIMAL POS
2
Cleared 510(K)
K
93
4725
PHX TECHNOLOGIES CORP., ISDS-2000, IRRIGATION SOLUTION DELIVERY SYSTEM
2
Cleared 510(K)
K
93
4076
PHX TECHNOLOGIES CORP., IRRIGATION SOLUTION DELIVERY SYSTEM, ISDS-1000
2
Cleared 510(K)
K
93
3192
ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.
2
Cleared 510(K)
K
93
2631
XENON LIGHT SOURCE ILLUMINATOR
2
Cleared 510(K)
K
93
2629
FIBER OPTIC LIGHT CABLE
2
Cleared 510(K)
K
93
3985
MICROWAVE INSURG INTRODUCER
2
Cleared 510(K)
K
93
3720
INSTRUMENT ACTUATING DEVICE (IAD)
2
Cleared 510(K)
K
92
6016
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE
2
Cleared 510(K)
K
92
5959
FORCEPS FOR LAPAROSCOPIC SURGERY GU USE
2
Cleared 510(K)
K
93
2697
ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR
2
Cleared 510(K)
K
93
1928
JARIT SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
3456
COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE
2
Cleared 510(K)
K
93
3421
ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES
2
Cleared 510(K)
K
93
2979
EXTERNAL STABILITY PAD
2
Cleared 510(K)
K
93
2698
ISI(R) HOOK SUTURES SCISSORS
2
Cleared 510(K)
K
93
3388
BRIMFIELD PRECISION SCISSOR
2
Cleared 510(K)
K
93
3243
KNOT PUSHER
2
Cleared 510(K)
K
93
3909
SCOPE WASH
2
Cleared 510(K)
K
93
3387
BRIMFIELD PRECISION GRASPER/DISSECTOR
2
Cleared 510(K)
K
92
6480
LAPAROSCOPIC BALLOON RETRACTOR
2
Cleared 510(K)
K
93
2648
QUICK SWITCH LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
92
2608
ENDOPATH EP DISPOSABLE TROCAR
2
Cleared 510(K)
K
93
0605
APPLIER, SURGICAL, CLIP
2
Cleared 510(K)
K
93
4134
DISTENTION INSTRUMENT, MODIFICATION
2
Cleared 510(K)
K
93
3160
PROCEDURE KITS
2
Cleared 510(K)
K
93
2885
AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP
2
Cleared 510(K)
K
93
2995
SURGICAL TROCAR AND CANNULA
2
Cleared 510(K)
K
93
2045
DISPOSABLE INSUFFLATION TUBING
2
Cleared 510(K)
K
92
3201
ENDOSI SUCTION IRRIGATOR
2
Cleared 510(K)
K
93
3104
ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG
2
Cleared 510(K)
K
93
3076
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
93
3032
LAPAROSCOPIC SURGICAL RETRACTOR
2
Cleared 510(K)
K
92
1103
RETRACTION INSTRUMENT
2
Cleared 510(K)
K
93
2976
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
2
Cleared 510(K)
K
93
2977
CABOT MEDICAL OPTIMA HAND INSTRUMENTS
2
Cleared 510(K)
K
93
1895
ENDOSCOPE ACCESSORY
2
Cleared 510(K)
K
93
1138
CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP
2
Cleared 510(K)
K
93
0463
LOCKING PIVOTAL THORACOPORT
2
Cleared 510(K)
K
93
3009
SURGICAL RETRACTOR/BLUNT DISSECTOR
2
Cleared 510(K)
K
92
5382
CUTTER, SURGICAL
2
Cleared 510(K)
K
93
3661
INSUFFLATOR TUBING KIT W/FILTER
2
Cleared 510(K)
K
93
3520
ENDOSCOPIC ANTI-FOG KIT, 100-302-00
2
Cleared 510(K)
K
93
3049
SRUGICAL RETRACTOR, MODIFICATION
2
Cleared 510(K)
K
93
1878
JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680
2
Cleared 510(K)
K
93
2229
SURGICAL TROCAR AND TROCAR SLEEVE
2
Cleared 510(K)
K
93
1518
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE
2
Cleared 510(K)
K
93
2804
IRRIGATING TAPERED PROBE
2
Cleared 510(K)
K
93
2805
10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT
2
Cleared 510(K)
K
93
2806
POOLE TIP SUCTION PROBE & TUBING KIT
2
Cleared 510(K)
K
93
1273
MIST FORCEPS/CLAMPS FOR LAPAROSCOPOIC/ENDOSCOPIC
2
Cleared 510(K)
K
93
0617
OBGRIP AND UNITIPS(TM)
2
Cleared 510(K)
K
93
3416
DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH
2
Cleared 510(K)
K
93
2604
UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC
2
Cleared 510(K)
K
93
0809
UNITIPS
2
Cleared 510(K)
K
92
5917
UNICHANNEL(TM SURGICAL GRASPER
2
Cleared 510(K)
K
92
5882
UNITIPS SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
2466
MEDCHEM SURGICAL DELIVERY SYSTEM
2
Cleared 510(K)
K
93
1706
ENDOSCOPIC CABLE DRAPE
2
Cleared 510(K)
K
93
1707
ENDOSCOPIC CABLE/WIRE COVER
2
Cleared 510(K)
K
93
1649
LAPAROSCOPIC BALLOON RETRACTOR
2
Cleared 510(K)
K
93
1262
REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR
2
Cleared 510(K)
K
92
6583
REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR
2
Cleared 510(K)
K
93
1275
MIST MICROSURGICAL MONOPOLAR FORCEPS
2
Cleared 510(K)
K
93
1274
MIST MICROSURGICAL MONOPOLAR SCISSORS
2
Cleared 510(K)
K
92
4372
LAPAROSCOPIC NERVE HOOK
2
Cleared 510(K)
K
93
2022
ENTREE THORACOSCOPY CANNULA SET
2
Cleared 510(K)
K
93
1898
ENDOSWAB
2
Cleared 510(K)
K
93
1223
FUJINON VIDEO LAPAROSCOPE--THORACOSCOPY
2
Cleared 510(K)
K
93
0817
LAPAROSCOPIC LYMPHADENECTOMY
2
Cleared 510(K)
K
92
5599
FUJINON VIDEO LAPAROSCOPE-ADDITIONAL INTENDED USE
2
Cleared 510(K)
K
93
1281
MICRO ENDOSCOPIC ELECTRODE (ME2)
2
Cleared 510(K)
K
93
1278
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
2
Cleared 510(K)
K
93
0716
LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION
2
Cleared 510(K)
K
93
0572
NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM II PUMP
2
Cleared 510(K)
K
92
6089
KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER
2
Cleared 510(K)
K
93
1705
ENDOSCOPIC INSTRUMENT HOLDER
2
Cleared 510(K)
K
93
0462
ENDOSCOPIC UMBRELLA RETRACTOR
2
Cleared 510(K)
K
92
5624
MICROSURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
0301
TROCAR SHEATH ANCHOR
2
Cleared 510(K)
K
92
4011
ORIGIN BLUNT TIP SURGICAL TROCAR
2
Cleared 510(K)
K
92
6110
ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT
2
Cleared 510(K)
K
92
5602
DAVIS+GECK ABSORBABLE LIGATING DEVICE
2
Cleared 510(K)
K
93
1142
INSTRUMENTS FOR LAPAROSCOPIC USE
2
Cleared 510(K)
K
93
1018
KARL STORZ 495N SERIES FIBER OPTIC LIGHT CABLES
2
Cleared 510(K)
K
93
0511
STEALTH SURGICAL IRRIGATOR ASPIRATOR
2
Cleared 510(K)
K
92
6444
FUJINON VIDEO LAPAROSCOPE, MODIFICATION
2
Cleared 510(K)
K
92
6010
SURGICAL DISSECTOR WITH CANNULA
2
Cleared 510(K)
K
92
5147
ORC 10.0MM SUCTION PROBE
2
Cleared 510(K)
K
92
4916
ENDOPATH ENDOSCOPIC TISSUE RETRACTOR
2
Cleared 510(K)
K
93
0550
ECO LIGATING CLIP
2
Cleared 510(K)
K
92
6335
IDEAS PEANUT WAND
2
Cleared 510(K)
K
93
2282
ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE
2
Cleared 510(K)
K
93
1237
ENDOPATH* DISPOSABLE INTRODUCER
2
Cleared 510(K)
K
93
1238
ENDOPATH DISPOSABLE KNOT PUSHER
2
Cleared 510(K)
K
93
1111
ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA
2
Cleared 510(K)
K
93
0933
ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
0147
SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY
2
Cleared 510(K)
K
93
1259
ENDOSCOPIC OR THORASCOPIC FORCEPS
2
Cleared 510(K)
K
93
0352
HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.
2
Cleared 510(K)
K
93
0464
BLUNT DISSECTING SCISSORS
2
Cleared 510(K)
K
93
0427
STD IRRIGATION PUMP
2
Cleared 510(K)
K
92
1208
ACCU-BEAM TUBE SET
2
Cleared 510(K)
K
92
1925
MANUAL SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
0465
WIRE GUIDED OVAL DILATORS
2
Cleared 510(K)
K
93
0466
COMPRESSION CLAMP
2
Cleared 510(K)
K
93
0467
BABCOCK FORCEPS, GRASPING FORCEPS, NEEDLE HOLDER
2
Cleared 510(K)
K
93
1272
MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDUR
2
Cleared 510(K)
K
92
6341
UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT
2
Cleared 510(K)
K
92
6078
DMI TOCAR AND CANNULA SYSTEM
2
Cleared 510(K)
K
92
5699
HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.
2
Cleared 510(K)
K
92
4931
NEEDLE, PNEUMOPERITONEUM, SPRING LOADED
2
Cleared 510(K)
K
93
1276
MIST RATCHETED FORCEPS FOR LAPAROSCOPIC/ENDOSCOPIC
2
Cleared 510(K)
K
92
1457
IRRIGATION PUMPS AND TUBING AND SUCTION TUBING
2
Cleared 510(K)
K
92
5914
PRE-TIED LOOP SUTURE CANNULA
2
Cleared 510(K)
K
93
1092
ENDOSCOPIC RETRACTOR
2
Cleared 510(K)
K
93
1337
AUTO SUTURE DILATING CANNULA
2
Cleared 510(K)
K
92
6214
GUIDE WIRE FOR LAPOROSCOPIC USE
2
Cleared 510(K)
K
93
0935
ENDOPATH TISSUE EXTRACTION CANNULA
2
Cleared 510(K)
K
92
5932
CANUSEAL
2
Cleared 510(K)
K
92
5860
MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL
2
Cleared 510(K)
K
92
5129
SELECTOR
2
Cleared 510(K)
K
92
4281
HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY
2
Cleared 510(K)
K
92
2987
LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.
2
Cleared 510(K)
K
92
2319
OMNI LAPAROSCOPE
2
Cleared 510(K)
K
93
0569
LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM
2
Cleared 510(K)
K
92
6223
ENDOSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
92
4761
STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD
2
Cleared 510(K)
K
92
0611
MARLOW LAPAROSCOPIC GRASPING FORCEP
2
Cleared 510(K)
K
93
0567
MODIFIED ENDOSCOPIC CLAMP
2
Cleared 510(K)
K
92
6079
DMI LAPAROSCOPIC ELECTRODES
2
Cleared 510(K)
K
92
4035
ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE
2
Cleared 510(K)
K
92
3726
KENSEY NASH DYNAMIC CLIP SYSTEM
2
Cleared 510(K)
K
92
6104
POLYP NET
2
Cleared 510(K)
K
92
2685
TROCARS
2
Cleared 510(K)
K
92
0595
ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER
2
Cleared 510(K)
K
92
4058
TROCAR
2
Cleared 510(K)
K
92
2797
AESCULAP TROCAR INSTRUMENT SET
2
Cleared 510(K)
K
92
4022
O.R. CONCEPTS SECONDARY CANNULA
2
Cleared 510(K)
K
92
2094
DISSECTION INSTRUMENT
2
Cleared 510(K)
K
93
0082
ENDOSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
92
3982
OLYMPUS OES LAPAROSCOPY SYSTEM
2
Cleared 510(K)
K
92
6282
MCKERNAN-POTTS GRASPING FORCEPS
2
Cleared 510(K)
K
92
6281
MCKERNAN-ADSON AGGRESSIVE FORCEPS
2
Cleared 510(K)
K
92
1287
SURGICAL RETRACTOR
2
Cleared 510(K)
K
92
3820
LAPAROSCOPIC SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
92
5824
SOLOS FAN RETRACTORS
2
Cleared 510(K)
K
92
5669
DEVMED LENS WASH SHEATH
2
Cleared 510(K)
K
92
5565
MAGNETIC RETRIEVER
2
Cleared 510(K)
K
92
5410
SYMBIOSIS HEMOSTATIC WAND
2
Cleared 510(K)
K
92
5198
KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR
2
Cleared 510(K)
K
92
5267
GRASPING FORCEPS OR RETRIEVAL FORCEPS
2
Cleared 510(K)
K
92
4284
MICROSURGE DIRECTOR ARTICULATING INSTRUMENTS
2
Cleared 510(K)
K
92
3547
MINIVASIVE LAPAROSCOPY INSTRUMENTS
2
Cleared 510(K)
K
92
3945
PLEATMAN SAC SPECIMEN CONTAINER
2
Cleared 510(K)
K
92
5149
AUTO SUTURE ENDOSCOPIC KNOT PUSHER
2
Cleared 510(K)
K
92
4149
ENDO I/A PROBE
2
Cleared 510(K)
K
92
4048
CABOT DISPOSABLE 10MM SUCTION DEVICE
2
Cleared 510(K)
K
92
3528
INLET IRRIGATION/ASPIRATION VALVE AND PROBES
2
Cleared 510(K)
K
92
4728
KNOT PUSHER
2
Cleared 510(K)
K
92
2435
LAPAROSCOPIC CURVED TRIANGLE RETRACTOR
2
Cleared 510(K)
K
92
1040
ENDOSCOPE
2
Cleared 510(K)
K
92
4592
DAVOL KNOT PUSHER
2
Cleared 510(K)
K
92
3219
URESIL SPECIMEN RETRIEVAL BAG
2
Cleared 510(K)
K
92
5041
MCKERNAN ATRAUMATIC FORCEPS
2
Cleared 510(K)
K
92
2424
ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.
2
Cleared 510(K)
K
92
3055
OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES
2
Cleared 510(K)
K
92
2751
ORIGIN FLEXIBLE PORT
2
Cleared 510(K)
K
92
1336
TROCAR GRASPER/ANVIL APPROXIMATOR
2
Cleared 510(K)
K
91
5317
PUTMAN STABILIZER
2
Cleared 510(K)
K
91
5790
ENDO-GARD ELECTROSURGICAL TROCAR
2
Cleared 510(K)
K
92
0068
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
2
Cleared 510(K)
K
92
2526
DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES
2
Cleared 510(K)
K
92
2246
TUBING SET W/ IRRIGATION & ASPIRATION VALVING
2
Cleared 510(K)
K
92
2405
O.R.C. ADAPTER
2
Cleared 510(K)
K
92
2571
INSTRUMENT, MANUAL, GENERAL SURGICAL
2
Cleared 510(K)
K
92
2082
LAPAROSCOPIC INTRODUCER
2
Cleared 510(K)
K
92
0599
HOOK SURGICAL INSTRUMENT
2
Cleared 510(K)
K
92
2655
SUCTION/IRRIGATION Y TUBING SET
2
Cleared 510(K)
K
92
2243
E-Z CLAMP#1 AND#2
2
Cleared 510(K)
K
92
1709
ENDOBAG, MODIFICATION
2
Cleared 510(K)
K
92
1260
LAPAROSCOPIC SURGICAL INSTRUMETNS
2
Cleared 510(K)
K
92
1922
GRICE LAPAROSCOPIC SUTURING NEEDLE
2
Cleared 510(K)
K
91
4752
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
2
Cleared 510(K)
K
92
1086
WOM LAPAROFLATOR ELECTRONIC
2
Cleared 510(K)
K
91
5372
MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY
2
Cleared 510(K)
K
91
5286
LAP TISSUE COLLECTION BAG
2
Cleared 510(K)
K
91
4922
UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG
2
Cleared 510(K)
K
91
4690
LM15(TM), CATALOG NUMBER - 523821
2
Cleared 510(K)
K
91
5099
ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN
2
Cleared 510(K)
K
91
5854
ENDOSCOPIC TRANSLUMINATOR
2
Cleared 510(K)
K
91
5544
LAPAROSCOPY SCISSORS
2
Cleared 510(K)
K
92
0040
INTRADUCER
2
Cleared 510(K)
K
92
0403
XENON ARC ENDOSCOPE LIGHT SOURCE
2
Cleared 510(K)
K
91
5360
LAPAROSCOPIC SNARE POUCH
2
Cleared 510(K)
K
91
4861
EVACUATION KIT #7-510-14
2
Cleared 510(K)
K
91
5298
SUCTION/IRRIGATION CANNULA; CATLOG #532.00
2
Cleared 510(K)
K
91
2859
FUJINON EVL-F
2
Cleared 510(K)
K
91
4084
ENDOSCOPES
2
Cleared 510(K)
K
91
5239
ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR
2
Cleared 510(K)
K
91
4869
MARLOW LAPAROSCOPIC SCISSORS
2
Cleared 510(K)
K
91
4919
SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM
2
Cleared 510(K)
K
91
4997
ASP-IRRATOR
2
Cleared 510(K)
K
91
1730
SURGICAL OBTURATOR WITH SEAL
2
Cleared 510(K)
K
91
3810
HOLMED HAND HELD INSTRUMENTS
2
Cleared 510(K)
K
91
3954
MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS
2
Cleared 510(K)
K
91
4781
SUCTION/IRRIGATION KITTNER
2
Cleared 510(K)
K
91
4782
SUCTION/IRRIGATION PROBE
2
Cleared 510(K)
K
91
4549
ETHICON ABSORBABLE SUTURE CLIP AND APPLIER
2
Cleared 510(K)
K
91
4470
PNEUMO-SEAL(TM)
2
Cleared 510(K)
K
91
4967
SHARP ENDOKNOT PUSHER
2
Cleared 510(K)
K
91
4547
LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM
2
Cleared 510(K)
K
91
4526
DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)
2
Cleared 510(K)
K
91
2247
UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY
2
Cleared 510(K)
K
91
3999
NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE
2
Cleared 510(K)
K
91
4377
TROCAR
2
Cleared 510(K)
K
91
4098
LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR
2
Cleared 510(K)
K
91
3762
MONOSCOPY(TM) BRAND, ENDOBAG
2
Cleared 510(K)
K
91
2492
EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE
2
Cleared 510(K)
K
91
2933
MEDICAM LAPAROSCOPY ENDOSCOPES
2
Cleared 510(K)
K
91
4203
LAPAROSCOPIC BALLOON RETRACTOR
2
Cleared 510(K)
K
91
3991
GRASPER, RATCHETED (5MM X 30CM)
2
Cleared 510(K)
K
91
3469
ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER
2
Cleared 510(K)
K
91
2973
ENDOSCOPE SUTURE & CARRIER
2
Cleared 510(K)
K
91
3500
CHERRY SPONGE
2
Cleared 510(K)
K
91
2927
AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE
2
Cleared 510(K)
K
91
2097
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
2
Cleared 510(K)
K
91
3870
5MM MICROSCISSORS
2
Cleared 510(K)
K
91
2556
DAVIS AND GECK LAPRO-LOOP LIGATURE CARRIER
2
Cleared 510(K)
K
91
3172
ENDOSCOPIC DELIVERY SYSTEM
2
Cleared 510(K)
K
91
2159
MAJOR SET-UP TRAY
2
Cleared 510(K)
K
91
2836
CANNULA AND TROCAR
2
Cleared 510(K)
K
91
2319
DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER
2
Cleared 510(K)
K
91
2903
PERCUTANEOUS RETRACTOR KIT
2
Cleared 510(K)
K
91
2862
MONOSCOPY(TM) BRANK, HOOK DISSECTOR
2
Cleared 510(K)
K
91
1105
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION
2
Cleared 510(K)
K
91
2750
MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR
2
Cleared 510(K)
K
91
3104
MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE
2
Cleared 510(K)
K
91
2980
MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED
2
Cleared 510(K)
K
91
2579
THE VOSS DISPOSABLE SUCTION/IRRIGATION CANNULA
2
Cleared 510(K)
K
91
1744
PRECISION OPTICS CORPORATION LAPAROSCOPE
2
Cleared 510(K)
K
91
2502
LAPAROSCOPIC LASER FIBER DIVERTER
2
Cleared 510(K)
K
91
1754
SCISSORS,GRASPERS,FORCEPS
2
Cleared 510(K)
K
91
2605
AMCATH DISPOSABLE MICRO SCISSORS
2
Cleared 510(K)
K
91
1589
DISPOSABLE SURGICAL TROCAR WITH SEAL
2
Cleared 510(K)
K
91
1164
REICH SUCTION/IRRIGATION CANNULA
2
Cleared 510(K)
K
91
1149
PAL (PROBE FOR ASPIRATION AND LAVAGE)
2
Cleared 510(K)
K
91
0985
SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
2
Cleared 510(K)
K
91
1494
NEEDLE CANNULA
2
Cleared 510(K)
K
91
1490
LAPAROSCOPE SUPPORT ARM
2
Cleared 510(K)
K
91
1489
PALPATATION AND MEASURING STICK
2
Cleared 510(K)
K
91
1243
CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP
2
Cleared 510(K)
K
91
2343
DISTENDABLE PALPATION PROBE
2
Cleared 510(K)
K
91
2023
LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR
2
Cleared 510(K)
K
91
1817
ENDOSCOPIC CLIP APPLIER
2
Cleared 510(K)
K
91
1488
LAPAROSCOPIC RINSING CONTAINER
2
Cleared 510(K)
K
91
1053
CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT
2
Cleared 510(K)
K
91
1478
LAPAROSCOPIC SNARE POUCH
2
Cleared 510(K)
K
91
0246
CORE DISPOSABLE SUCTION/IRRIGATION TUBING
2
Cleared 510(K)
K
91
1493
LAPAROSCOPIC IRRIGATION PUMP
2
Cleared 510(K)
K
91
1486
LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
2
Cleared 510(K)
K
91
1157
APPLICATOR LOOP SUTURES
2
Cleared 510(K)
K
91
1484
LAPAROSCOPIC SUCTION IRRIGATION TUBING SET
2
Cleared 510(K)
K
91
0132
STRYKER LAPAROSCOPE
2
Cleared 510(K)
K
89
4716
DIRECTABLE COAXIAL CATHETER SET
2
Cleared 510(K)
K
86
2611
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES
2
Cleared 510(K)
K
83
3189
HYDROFLOW SUCTION IRRIGATION SYSTEM
2
Cleared 510(K)
K
83
0719
UNIVERSAL CANNULA
2
Cleared 510(K)
K
82
3581
ELPHA 500
2
Cleared 510(K)
K
77
0712
TROCAR SLEEVE SYSTEM 4MM TO 3.4MM
2
Cleared 510(K)
K
77
0711
TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM
2
Cleared 510(K)
K
77
0348
TROCAR SLEEVE SYSTEM, EXTENDED
2
Cleared 510(K)
MFJ
Device, Endoscopic Suturing
2
Product Code
EPY
Speculum, Ent
1
Product Code
NAY
System, Surgical, Computer Controlled Instrument
2
Product Code
NEQ
Device, Telemedicine, Robotic
2
Product Code
PDT
Burn Resuscitation Decision Support Software
2
Product Code
FDP
Apparatus, Pneumoperitoneum, Automatic
2
Product Code
GCG
Peritoneoscope
2
Product Code
GCH
Mediastinoscope, Diagnostic
2
Product Code
OTJ
Laparoscopic Single Port Access Device
2
Product Code
OWN
Confocal Optical Imaging
2
Product Code
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
2
Product Code
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
2
Product Code
POY
Post Breast Biopsy Hemostatic Breast Compression Device
2
Product Code
FXE
Speculum, Non-Illuminated
1
Product Code
FXF
Speculum, Illuminated
1
Product Code
FXG
Specula Accessories
1
Product Code
JYK
Holder, Ear Speculum
1
Product Code
KAG
Holder, Speculum, Ent
1
Product Code
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
2
Product Code
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 29 September 2023 at 11:04 pm
SU
/
subpart-b—diagnostic-devices
/
GCJ
/
K152513
View Source
8X-10-XXXX Camera System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152513
510(k) Type
Traditional
Applicant
Santa Barbara Imaging Systems
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/15/2015
Days to Decision
104 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
GCI
Laryngoscope, Endoscope
GCJ
Laparoscope, General & Plastic Surgery
K
23
2157
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
K
23
1400
Bladeless Trocar – Artemis Lap Cannula
K
23
1003
Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
K
23
1358
Universal Seal (5-12 mm)
K
23
0359
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (2617
K
23
0886
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
K
23
1042
Disposable Laparoscopic Trocar
K
22
3718
HandX™ Self-Righting Needle Holder
K
22
3562
Xpan Universal Trocar System
K
23
0491
HandX™ Monopolar Scissors
K
23
0058
Bladeless Trocar – Artemis Lap Cannula
K
23
0605
1788 4K Camera System with Advanced Imaging Modality
K
22
3923
HOPKINS Telescopes
K
22
3593
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
K
22
2828
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
K
22
3116
8X-10-6XXX Camera Head
K
22
3759
Arthrex SynergyID Endoscopic Imaging System
K
23
0216
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
K
22
1591
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
K
22
1861
FloNavi Endoscopic Fluorescence Imaging System
K
22
1781
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
K
21
3597
MultiCut Solo
K
22
1252
Scivita 4KINSIGHT ICG Imaging System
K
22
2011
HandX Instrument - Monopolar Spatula
K
22
1004
HOPKINS Telescopes
K
22
2575
HurriChem Device Kit
K
21
2736
Canady Flex RoboWrist
K
22
2504
H1
K
22
1740
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
K
22
2890
RADIANCE ULTRA 32 4K ZEROWIRE DUO
K
22
2079
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
K
22
1533
Plasma Shield
K
22
1365
LapBox Tissue Containment Removal System
K
22
2130
1688 4K Camera System with Advanced Imaging Modality
K
21
3818
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
K
21
1148
CORE-Trocar
K
22
1217
SPY Laparoscope
K
21
4046
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
K
22
0895
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
K
22
0872
Saberscope5 Laparoscope
K
21
1043
Alexis Contained Extraction System
K
21
3860
ArthroFree Wireless Surgical Camera System
K
22
0069
4K UHD LCD Monitor OEV321UH
K
22
0108
SDC4K Information Management System with Device and Voice Control Package
K
21
2055
Connected OR Hub with Device and Voice Control
K
21
2500
ArtiSential Trocar
K
21
2950
FUJIFILM Video Laparoscope EL-R740M30
K
21
1577
SoftFix Balloon Trocar
K
21
2511
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
K
21
1234
RedEx
K
21
2214
HandX
K
21
0248
Lab Bag with Fabric Pouch
K
20
2582
Arthrex SynergyID Endoscopic Imaging System
K
20
3717
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
K
20
2551
Cor-Knot Micro
K
21
1250
VisionPort System
K
21
0495
Port Access System
K
21
0088
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
K
21
0584
SDC3 HD Information Management System with Wireless Device Control Capability
K
20
3255
4K UHD Laparoscope
K
20
2303
CORE E3 Suction/irrigator
K
20
3603
Monopolar Hook
K
20
1526
TIPCAM1 Rubina Video Endoscope System
K
20
2931
Disposable Trocar
K
20
2592
Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)
K
20
1134
Arthrex NanoScope System
K
20
1805
VersaOne Reusable Positioning Trocar System
K
20
2130
FUJIFILM Video Laparoscope
K
20
1641
Disposable Laparoscope Trocar
K
19
2499
Cyber Blade
K
20
1434
Connected OR Hub with Voice Control, Connected OR Hub with Device Control
K
20
1198
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
K
20
1243
Disposable Specimen Retrieval Bag
K
19
3272
GTK Trocars
K
20
1593
Looking Glass 4K Integrated Visualization System
K
20
1151
O-Mec 690 Series Laparoscopes
K
20
0902
ClickClean
K
19
1866
GelPOINT Mini Advanced Access Platform
K
20
0053
DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
K
19
3161
Pristine Scope
K
19
1930
7 mm Extended Length Endoscope
K
20
0517
Standard Trocar
K
19
3026
Visera Elite II Video System Center, Visera Elite II Endoeye 3D
K
19
2300
EnlightenVue Microendoscopy System
K
20
0310
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
K
19
2918
Video Laparoscope, Video Processor, Light Source
K
20
0228
ClearCam System
K
19
3315
Xenocor Articulating Xenoscope Laparoscope
K
19
1678
IP Converter
K
19
3137
EASYGRIP FLO-41 Precision MIS Delivery System
K
19
2643
Dannik Laparoscopic Suction Irrigation System
K
19
2891
Laparoscope Lens Shield Device (LENS)
K
19
0029
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
K
18
3675
3D Visualization System
K
19
2172
Connected OR Hub with Device and Voice Control
K
19
1177
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
K
19
1295
Percutaneous Introducer Needle
K
19
0645
Arthrex NanoScope System
K
19
1043
da Vinci Handheld Camera
K
19
0831
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
K
19
0592
YelloPort Elite Port Access System
K
19
0788
Disposable Standard Clamp
K
18
1173
ELMED Laparoscopic Instruments and Accessories
K
18
3600
Anchor Bag-Alone Tissue Retrieval System by ConMed
K
18
3264
Flex-THOR scope
K
18
2434
LaparoGuard
K
18
2606
PINPOINT Endoscopic Fluorescence Imaging System
K
17
3917
neoClose PDS
K
18
2160
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
K
18
1258
ConnectedOR Hub with Device and Voice Control
K
18
1608
Disposable Standard Clamp
K
18
2080
Scope Antifogging System
K
17
3822
Anchor Tissue Retrieval System by CONMED
K
18
2024
Dissecting Balloon System
K
18
1791
SIMPLYSTRONG, SIMPLYEZEE
K
18
1395
Universal Cannula Seal (5-12 mm)
K
18
0977
KARL STORZ New Generation Trocars
K
18
0836
Genistrong
K
18
0208
Disposable Endoscopic Trocar
K
18
0114
AEON Retrieval Bag
K
17
3919
HX Device
K
18
0579
Ezee Retrieval
K
17
1939
ALVUE Balloon Dilation System
K
17
0683
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments