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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Microbiology
Review Panel
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Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
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Physical Medicine
Review Panel
Radiology
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General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
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
EMF
Knife, Surgical
1
Product Code
EPT
Microscope, Surgical
1
Product Code
EPW
Support, Head, Surgical, Ent
1
Product Code
OEJ
Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia
2
Product Code
FAZ
System, Cryosurgical, Liquid Nitrogen, For Urology
2
Product Code
OEK
Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
2
Product Code
GAG
Stapler, Surgical
2
Product Code
DWG
Electrosurgical Device
2
Product Code
DWH
Blade, Saw, Surgical, Cardiovascular
1
Product Code
DWI
Saw, Electrically Powered
1
Product Code
DWO
Needle, Biopsy, Cardiovascular
1
Product Code
QQS
Stapler, Skin
1
Product Code
BTA
Pump, Portable, Aspiration (Manual Or Powered)
2
Product Code
BWA
Unit, Electrosurgical And Coagulation, With Accessories
2
Product Code
BWN
Table And Attachments, Operating-Room
1
Product Code
BWP
Shoe And Shoe Cover, Conductive
1
Product Code
FGY
Cannula, Injection
1
Product Code
FHM
Apparatus, Suturing, Stomach And Intestinal
1
Product Code
FHR
Needle, Gastro-Urology
1
Product Code
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
2
Product Code
FNW
Pad, Kelly
2
Product Code
FQO
Table, Operating-Room, Ac-Powered
1
Product Code
FQP
Lamp, Operating-Room
2
Product Code
FSE
Table, Operating-Room, Manual
1
Product Code
FSH
Tray, Surgical, Needle
1
Product Code
FSM
Tray, Surgical, Instrument
1
Product Code
FSO
Microscope, Surgical, General & Plastic Surgery
1
Product Code
FSP
Loupe, Diagnostic/Surgical
1
Product Code
FSQ
Light, Surgical, Instrument
2
Product Code
FSS
Light, Surgical, Floor Standing
2
Product Code
FST
Light, Surgical, Fiberoptic
2
Product Code
FSW
Light, Surgical, Endoscopic
2
Product Code
FSX
Light, Surgical, Connector
2
Product Code
FSY
Light, Surgical, Ceiling Mounted
2
Product Code
FSZ
Light, Surgical, Carrier
2
Product Code
FTA
Light, Surgical, Accessories
2
Product Code
FTC
Light, Ultraviolet, Dermatological
2
Product Code
FTD
Lamp, Surgical
2
Product Code
FTF
Illuminator, Non-Remote
2
Product Code
FTG
Illuminator, Remote
2
Product Code
FTH
Camera, Still, Microsurgical
1
Product Code
FTS
Camera, Cine, Endoscopic, With Audio
1
Product Code
FTT
Camera, Still, Surgical
1
Product Code
FTX
Mirror, General & Plastic Surgery
1
Product Code
FTY
Tape, Measuring, Rulers And Calipers
1
Product Code
FWB
Camera, Television, Surgical, Without Audio
1
Product Code
FWC
Camera, Television, Surgical, With Audio
1
Product Code
FWD
Camera, Television, Microsurgical, Without Audio
1
Product Code
FWE
Camera, Television, Microsurgical, With Audio
1
Product Code
FWF
Camera, Television, Endoscopic, Without Audio
1
Product Code
FWG
Camera, Television, Endoscopic, With Audio
1
Product Code
FWH
Camera, Cine, Surgical, Without Audio
1
Product Code
FWI
Camera, Cine, Surgical, With Audio
1
Product Code
FWJ
Camera, Cine, Microsurgical, Without Audio
1
Product Code
FWK
Camera, Cine, Microsurgical, With Audio
1
Product Code
FWL
Camera, Cine, Endoscopic, Without Audio
1
Product Code
FWW
Table, Operating-Room, Pneumatic
1
Product Code
FWX
Table, Operating-Room, Mechanical
1
Product Code
FWY
Table, Operating-Room, Non-Electrical
1
Product Code
FWZ
Operating Room Accessories Table Tray
1
Product Code
FXM
Camera, Still, Endoscopic
1
Product Code
FXN
Tape, Camera, Surgical
1
Product Code
FXQ
Lens, Camera, Surgical
1
Product Code
FXR
Holder, Camera, Surgical
1
Product Code
FXS
Frame, Camera, Surgical
1
Product Code
FXT
Film, Camera, Surgical
1
Product Code
FXW
Shoes, Operating-Room
1
Product Code
FYE
Dress, Surgical
1
Product Code
FYF
Cap, Surgical
1
Product Code
FZK
Chair, Surgical, Non-Electrical
1
Product Code
FZM
Stool, Operating-Room
1
Product Code
FZO
Chisel, Surgical, Manual
1
Product Code
FZP
Clip, Implantable
2
Product Code
FZQ
Clip, Removable (Skin)
1
Product Code
FZR
Contractor, Surgical
1
Product Code
FZS
Curette, Surgical, General Use
1
Product Code
FZT
Cutter, Surgical
1
Product Code
FZW
Expander, Surgical, Skin Graft
1
Product Code
FZX
Guide, Surgical, Instrument
1
Product Code
FZY
Hammer, Surgical
1
Product Code
FZZ
Marker, Skin
1
Product Code
GAA
Needle, Aspiration And Injection, Disposable
1
Product Code
GAB
Needle, Suturing, Disposable
1
Product Code
GAC
Rasp, Surgical, General & Plastic Surgery
1
Product Code
GAD
Retractor
1
Product Code
GAE
Snare, Surgical
1
Product Code
GAF
Spatula, Surgical, General & Plastic Surgery
1
Product Code
GAH
Stylet, Surgical, General & Plastic Surgery
1
Product Code
GAI
Stripper, Vein, Reusable
1
Product Code
GAJ
Stripper, Vein, Disposable
1
Product Code
GAK
Suture, Absorbable
2
Product Code
GAL
Suture, Absorbable, Natural
2
Product Code
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
2
Product Code
GAN
Suture, Absorbable, Synthetic
2
Product Code
GAO
Suture, Nonabsorbable
2
Product Code
GAP
Suture, Nonabsorbable, Silk
2
Product Code
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
2
Product Code
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
2
Product Code
GAS
Suture, Nonabsorbable, Synthetic, Polyester
2
Product Code
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
2
Product Code
GAW
Suture, Nonabsorbable, Synthetic, Polypropylene
2
Product Code
GBA
Catheter, Balloon Type
1
Product Code
GBB
Chair, Surgical, Ac-Powered
1
Product Code
GBC
Lamp, Surgical, Incandescent
2
Product Code
GBN
Catheter, Pediatric, General & Plastic Surgery
1
Product Code
GBO
Catheter, Nephrostomy, General & Plastic Surgery
1
Product Code
GBP
Catheter, Multiple Lumen
1
Product Code
GBQ
Catheter, Continuous Irrigation
1
Product Code
GBS
Catheter, Ventricular, General & Plastic Surgery
1
Product Code
GBW
Catheter, Peritoneal
1
Product Code
GBX
Catheter, Irrigation
1
Product Code
GBY
Catheter, Eustachian, General & Plastic Surgery
1
Product Code
GBZ
Catheter, Cholangiography
1
Product Code
GCB
Needle, Catheter
1
Product Code
GCC
Dilator, Catheter
1
Product Code
GCD
Connector, Catheter
1
Product Code
GCE
Adaptor, Catheter
1
Product Code
GCY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
1
Product Code
GCZ
Retainer, Surgical
1
Product Code
GDC
Table, Operating-Room, Electrical
1
Product Code
GDF
Guide, Needle, Surgical
1
Product Code
GDG
Hook, Surgical, General & Plastic Surgery
1
Product Code
GDH
Gouge, Surgical, General & Plastic Surgery
1
Product Code
GDI
Dissector, Surgical, General & Plastic Surgery
1
Product Code
GDJ
Clamp, Surgical, General & Plastic Surgery
1
Product Code
GDL
Needle, Suturing, Reusable
1
Product Code
GDM
Needle, Aspiration And Injection, Reusable
1
Product Code
GDN
Knife, Amputation
1
Product Code
GDO
Applier, Surgical, Clip
1
Product Code
GDR
Saw, Manual And Accessories
1
Product Code
GDT
Staple, Removable (Skin)
1
Product Code
GDW
Staple, Implantable
2
Product Code
K
24
1630
ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)
2
Cleared 510(K)
K
24
2679
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)
2
Cleared 510(K)
K
22
2487
Anika Tissue Tack Fixation System
2
Cleared 510(K)
K
22
2210
AEON Endoscopic Stapler
2
Cleared 510(K)
K
22
3760
ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)
2
Cleared 510(K)
K
21
1197
Disposable Endoscopic Cutter Stapler and Cartridge
2
Cleared 510(K)
K
22
1771
EEA Circular Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
22
2641
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
2
Cleared 510(K)
K
22
1003
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
2
Cleared 510(K)
K
22
1013
GIA Auto Suture Stapler with DST Series Technology
2
Cleared 510(K)
K
22
1006
GIA Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
22
1005
EEA Circular Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
21
1811
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
2
Cleared 510(K)
K
21
1458
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
2
Cleared 510(K)
K
20
1934
Surgimatix Absorbable Fixation System
2
Cleared 510(K)
K
21
0909
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
2
Cleared 510(K)
K
20
1639
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
2
Cleared 510(K)
K
20
2709
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
2
Cleared 510(K)
K
21
0278
Titan SGS
2
Cleared 510(K)
K
20
0320
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
2
Cleared 510(K)
K
20
2507
EEA Circular Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
20
3117
TissueTak device
2
Cleared 510(K)
K
20
2467
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
2
Cleared 510(K)
K
20
2701
GIA Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
20
2864
Tri-Staple 2.0 Reloads
2
Cleared 510(K)
K
20
2665
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
2
Cleared 510(K)
K
20
1882
AEON Endoscopic Stapler
2
Cleared 510(K)
K
20
1280
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
2
Cleared 510(K)
K
20
1672
Signia Stapler (with new software)
2
Cleared 510(K)
K
20
0420
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
2
Cleared 510(K)
K
19
2720
GIA Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
19
2330
EEA Circular Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
19
0884
TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
2
Cleared 510(K)
K
18
2476
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
2
Cleared 510(K)
K
19
0331
Applied Medical Laparoscopic Linear Cutter
2
Cleared 510(K)
K
19
2566
Reach and CQ'ENCE Circular Staplers
2
Cleared 510(K)
K
19
1070
Signia Small Diameter Reloads
2
Cleared 510(K)
K
19
1287
OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
2
Cleared 510(K)
K
18
2217
Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
2
Cleared 510(K)
K
18
2475
Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
2
Cleared 510(K)
K
18
1668
FasTouch Absorbable Fixation System
2
Cleared 510(K)
K
18
3477
easyPPHTM Hemorrhoidal Stapler for Single Use
2
Cleared 510(K)
K
18
3435
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
2
Cleared 510(K)
K
18
1657
easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
2
Cleared 510(K)
K
18
0175
SignalMark Lung Biopsy Site Marker
2
Cleared 510(K)
K
18
2380
AEON Endoscopic Stapler
2
Cleared 510(K)
K
18
1653
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
2
Cleared 510(K)
K
18
1620
Endoscopic Linear Cutting Staplers and Loading Units for Single Use
2
Cleared 510(K)
K
17
3270
Tri-Staple 2.0 Reinforced Reload
2
Cleared 510(K)
K
17
2361
EEA Circular Stapler with Tri-Staple Technology
2
Cleared 510(K)
K
17
3443
AEON Endoscopic Stapler
2
Cleared 510(K)
K
17
2960
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
2
Cleared 510(K)
K
17
2561
Disposable Circular Stapler
2
Cleared 510(K)
K
17
2538
Disposable Linear Stapler, Disposable Linear Cutter
2
Cleared 510(K)
K
17
1589
AEON Endoscopic Stapler
2
Cleared 510(K)
K
17
1561
Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
2
Cleared 510(K)
K
16
2707
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
2
Cleared 510(K)
K
17
0278
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
2
Cleared 510(K)
K
16
3523
ECHELON CIRCULAR Powered Stapler
2
Cleared 510(K)
K
16
3698
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
2
Cleared 510(K)
K
16
2947
Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler
2
Cleared 510(K)
K
17
0348
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
2
Cleared 510(K)
K
16
2710
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
2
Cleared 510(K)
K
16
3454
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
2
Cleared 510(K)
K
16
0969
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
2
Cleared 510(K)
K
16
3098
Tri-Staple 2.0 Intelligent Cartridge
2
Cleared 510(K)
K
16
1757
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
2
Cleared 510(K)
K
16
1905
Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
2
Cleared 510(K)
K
16
2252
FasTouch Fixation System
2
Cleared 510(K)
K
16
1137
Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
2
Cleared 510(K)
K
16
0900
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
2
Cleared 510(K)
K
16
0176
Signia Stapler
2
Cleared 510(K)
K
15
3202
iMESH Tacker
2
Cleared 510(K)
K
16
0521
ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
2
Cleared 510(K)
K
15
1081
MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
2
Cleared 510(K)
K
15
2618
PANTHER Cutter Stapler
2
Cleared 510(K)
K
15
1659
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
2
Cleared 510(K)
K
14
2577
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
2
Cleared 510(K)
K
15
1163
Signia Loading Unit, Tri-Staple 2.0 Cartridge
2
Cleared 510(K)
K
15
0026
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
2
Cleared 510(K)
K
14
2873
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
2
Cleared 510(K)
K
14
2808
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
2
Cleared 510(K)
K
14
3129
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
2
Cleared 510(K)
K
14
1952
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
2
Cleared 510(K)
K
14
1097
CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
2
Cleared 510(K)
K
14
1367
LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
2
Cleared 510(K)
K
14
0560
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
2
Cleared 510(K)
K
14
0609
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
2
Cleared 510(K)
K
13
1563
SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
2
Cleared 510(K)
K
13
2698
FASTOUCH FIXATION SYSTEM
2
Cleared 510(K)
K
14
0118
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
2
Cleared 510(K)
K
14
0170
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
2
Cleared 510(K)
K
13
2472
JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
2
Cleared 510(K)
K
13
3938
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
2
Cleared 510(K)
K
13
3499
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA
2
Cleared 510(K)
K
13
2669
PROXIFAST ABSORBABLE STAPLE
2
Cleared 510(K)
K
13
3762
ENDO GIA(TM) EXTRA LONG ADAPTER
2
Cleared 510(K)
K
13
2581
MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
2
Cleared 510(K)
K
13
0738
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
2
Cleared 510(K)
K
13
2134
OPTIFIX ABSORBABLE FIXATION SYSTEM
2
Cleared 510(K)
K
13
2493
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
2
Cleared 510(K)
K
13
1663
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
2
Cleared 510(K)
K
13
1637
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
2
Cleared 510(K)
K
13
1511
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
2
Cleared 510(K)
K
13
1705
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
2
Cleared 510(K)
K
13
1303
DISPOSABLE CIRCULAR STAPLER
2
Cleared 510(K)
K
13
0717
ENDO GIA RELOAD
2
Cleared 510(K)
K
13
0653
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU
2
Cleared 510(K)
K
12
3114
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
2
Cleared 510(K)
K
12
2781
RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
2
Cleared 510(K)
K
12
3718
PERMASORB DISPOSABLE FIXATION DEVICE
2
Cleared 510(K)
K
12
3318
IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
2
Cleared 510(K)
K
12
3109
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
2
Cleared 510(K)
K
12
1510
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
2
Cleared 510(K)
K
12
1600
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
2
Cleared 510(K)
K
12
1474
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
2
Cleared 510(K)
K
12
0179
REACH SURGICAL STAPLERS
2
Cleared 510(K)
K
12
0373
INSORB ABSORBALBE STAPLE
2
Cleared 510(K)
K
12
0258
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
2
Cleared 510(K)
K
12
0268
AMID STAPLER
2
Cleared 510(K)
K
11
2056
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
2
Cleared 510(K)
K
11
1825
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
2
Cleared 510(K)
K
11
1195
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
2
Cleared 510(K)
K
11
1111
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
2
Cleared 510(K)
K
11
0728
IMESH TACKER
2
Cleared 510(K)
K
11
1153
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
2
Cleared 510(K)
K
11
1064
TIGERPAW SYSTEM II
2
Cleared 510(K)
K
10
3672
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
2
Cleared 510(K)
K
11
0385
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
2
Cleared 510(K)
K
11
0049
REUSABLE LINEAR STAPLER HANDLE
2
Cleared 510(K)
K
10
3470
PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
2
Cleared 510(K)
K
10
3263
ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY
2
Cleared 510(K)
K
10
1961
TIGERPAW SYSTEM
2
Cleared 510(K)
K
10
2325
IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
2
Cleared 510(K)
K
10
2632
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
2
Cleared 510(K)
K
10
2291
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
2
Cleared 510(K)
K
10
1378
FRANKENMAN SURGICAL STAPLERS
2
Cleared 510(K)
K
10
1444
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
2
Cleared 510(K)
K
10
0723
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5
2
Cleared 510(K)
K
09
3845
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
2
Cleared 510(K)
K
10
0386
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
2
Cleared 510(K)
K
09
2483
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
2
Cleared 510(K)
K
09
3402
AUTOSUTURE EEA ORVIL
2
Cleared 510(K)
K
09
3410
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
2
Cleared 510(K)
K
09
3253
AMID STAPLER
2
Cleared 510(K)
K
09
2577
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
2
Cleared 510(K)
K
09
1900
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
2
Cleared 510(K)
K
09
0821
CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L
2
Cleared 510(K)
K
09
1322
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
2
Cleared 510(K)
K
09
1215
INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
2
Cleared 510(K)
K
08
3519
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS
2
Cleared 510(K)
K
09
0159
INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
2
Cleared 510(K)
K
08
3781
EEA HEMORRHOID STAPLER & ACCESSORIES
2
Cleared 510(K)
K
08
2396
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
2
Cleared 510(K)
K
08
3527
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
2
Cleared 510(K)
K
07
1023
REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
2
Cleared 510(K)
K
08
1826
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
2
Cleared 510(K)
K
08
0972
ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
2
Cleared 510(K)
K
08
1146
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
2
Cleared 510(K)
K
08
0839
ECHELON GRAY CARTRIDGE, MODEL ERC45M
2
Cleared 510(K)
K
08
0898
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT
2
Cleared 510(K)
K
07
3001
IDRIVES, IDRIVEC, IDRIVEF
2
Cleared 510(K)
K
07
3148
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
2
Cleared 510(K)
K
07
1920
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
2
Cleared 510(K)
K
07
1708
I45, I45S, I60, AND I60S
2
Cleared 510(K)
K
07
0887
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
2
Cleared 510(K)
K
07
1061
ABSORBATACK AND APPLICATOR
2
Cleared 510(K)
K
06
2869
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
2
Cleared 510(K)
K
06
3746
POWER EXTENDERS MODEL# PEC200, PES200,PES200S
2
Cleared 510(K)
K
06
3075
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
2
Cleared 510(K)
K
06
2850
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
2
Cleared 510(K)
K
06
1649
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH
2
Cleared 510(K)
K
06
1784
INSORB ABSORBABLE STAPLE, MODEL 1020
2
Cleared 510(K)
K
06
1156
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
2
Cleared 510(K)
K
06
0494
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
2
Cleared 510(K)
K
06
1095
AUTO SUTUR ENDO GIA STAPLERS
2
Cleared 510(K)
K
05
3631
CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
2
Cleared 510(K)
K
05
2910
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
2
Cleared 510(K)
K
05
2415
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
2
Cleared 510(K)
K
05
1301
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
2
Cleared 510(K)
K
05
1848
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
2
Cleared 510(K)
K
05
0610
SALUTE FIXATION SYSTEM
2
Cleared 510(K)
K
05
1002
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
2
Cleared 510(K)
K
04
2492
HAND STC, MODEL 60MM
2
Cleared 510(K)
K
04
1159
JMS ABSORBABLE ANCHOR AND APPLICATOR
2
Cleared 510(K)
K
04
1331
BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
2
Cleared 510(K)
K
04
1201
ULTRACLIP II MR
2
Cleared 510(K)
K
04
0720
SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM
2
Cleared 510(K)
K
04
0109
HEMORRHAGE OCCLUDER PIN
2
Cleared 510(K)
K
04
0398
SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS
2
Cleared 510(K)
K
04
0038
CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G
2
Cleared 510(K)
K
04
0024
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
2
Cleared 510(K)
K
03
2973
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
2
Cleared 510(K)
K
03
3602
INSORB ABSORBABLE STAPLE, MODEL SP-B20
2
Cleared 510(K)
K
03
2696
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
2
Cleared 510(K)
K
03
2701
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
2
Cleared 510(K)
K
03
2347
BIOMARC TISSUE MARKER
2
Cleared 510(K)
K
03
0925
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
2
Cleared 510(K)
K
02
4117
INSORB ABSORBABLE STAPLES, MODEL SP-B20
2
Cleared 510(K)
K
03
0653
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
2
Cleared 510(K)
K
03
0411
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
2
Cleared 510(K)
K
02
4275
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
2
Cleared 510(K)
K
02
3725
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247
2
Cleared 510(K)
K
02
2313
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V
2
Cleared 510(K)
K
02
0804
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
2
Cleared 510(K)
K
02
1701
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
2
Cleared 510(K)
K
02
0779
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
2
Cleared 510(K)
K
02
1249
SURGASSIST FLEXSHAFT 2, MODEL FS2 14
2
Cleared 510(K)
K
02
0719
SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
2
Cleared 510(K)
K
02
0343
SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL
2
Cleared 510(K)
K
01
4286
SALUTE, MODEL 3022
2
Cleared 510(K)
K
01
3749
ENDOANCHOR AND OPENANCHOR
2
Cleared 510(K)
K
01
3860
AUTO SUTURE SURGICAL STAPLES
2
Cleared 510(K)
K
01
2809
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
2
Cleared 510(K)
K
01
2362
MODIFICATION TO VASCULAR CLOSURE DEVICE
2
Cleared 510(K)
K
00
1807
TISSUE MARKER
2
Cleared 510(K)
K
00
3522
SALUTE
2
Cleared 510(K)
K
00
3277
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
2
Cleared 510(K)
K
00
3169
VASCULAR CLOSURE DEVICE
2
Cleared 510(K)
K
00
1895
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
2
Cleared 510(K)
K
00
0060
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
2
Cleared 510(K)
K
00
0608
SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
2
Cleared 510(K)
K
99
3785
ULTRACLIP TISSUE MARKER
2
Cleared 510(K)
K
99
1030
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
2
Cleared 510(K)
K
98
3318
FIXATION SYSTEM
2
Cleared 510(K)
K
98
3400
AUTO SUTURE SITE MARKER CLIP
2
Cleared 510(K)
K
98
3536
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
2
Cleared 510(K)
K
98
0617
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
2
Cleared 510(K)
K
97
0817
MICROMARK CLIP
2
Cleared 510(K)
K
96
3015
SURGICAL STAPLE MARKER DEVICE (MODIFY)
2
Cleared 510(K)
K
95
2239
AUTO SUTURE* MODIFIED LINEAR STAPLER**
2
Cleared 510(K)
K
95
0006
SURGICAL STAPLE MARKER
2
Cleared 510(K)
K
94
2606
SURGICAL STAPLE
2
Cleared 510(K)
K
93
1103
STRYKER STAPLER SYSTEM
2
Cleared 510(K)
K
93
1056
DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING
2
Cleared 510(K)
K
92
2186
HEM-O-LOK -- MODIFICATION
2
Cleared 510(K)
K
92
0752
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
2
Cleared 510(K)
K
92
1051
3M PRECISE BRAND INTERNAL SURGICAL STAPLES
2
Cleared 510(K)
K
91
5693
PROXIMATE ABSORBABLE STAPLES
2
Cleared 510(K)
K
91
5489
AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE
2
Cleared 510(K)
K
91
4130
AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES
2
Cleared 510(K)
K
91
3802
AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER
2
Cleared 510(K)
K
91
3832
AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER
2
Cleared 510(K)
K
91
3211
AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER
2
Cleared 510(K)
K
91
3411
DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING
2
Cleared 510(K)
K
91
3139
IMPLANTABLE METAL STAPLES
2
Cleared 510(K)
K
91
1252
PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
2
Cleared 510(K)
K
91
0897
PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X
2
Cleared 510(K)
K
91
0192
AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER
2
Cleared 510(K)
K
90
5106
AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER
2
Cleared 510(K)
K
90
0129
MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
2
Cleared 510(K)
K
90
0055
MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS
2
Cleared 510(K)
K
90
0043
MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER
2
Cleared 510(K)
K
89
2233
AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER
2
Cleared 510(K)
K
89
0841
TITANIUM STAPLES
2
Cleared 510(K)
K
89
0270
AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*
2
Cleared 510(K)
K
89
0447
HEMORRHAGE OCCLUDOR
2
Cleared 510(K)
K
88
5222
PRECISE ILA AND ILAN SURGICAL STAPLES
2
Cleared 510(K)
K
88
1484
BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING
2
Cleared 510(K)
K
87
3748
RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT
2
Cleared 510(K)
K
86
4146
DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)
2
Cleared 510(K)
K
85
5047
AUTO SUTURE TITANIUM SURGICAL STAPLES
2
Cleared 510(K)
K
85
1122
PI-PNEUMO INTESTINAL STAPLING CARTRIDGE
2
Cleared 510(K)
K
84
3399
SURGEONS CHOICE PI VASCULAR STAPLING
2
Cleared 510(K)
K
84
3603
AUTO SUTURE POLY GIA SURGICAL STAPLER
2
Cleared 510(K)
K
84
3034
DISPOSABLE LINEAR CUTTER
2
Cleared 510(K)
K
83
3698
AMER. V. MUELLER SURG. STAPLES ILA
2
Cleared 510(K)
K
83
3704
AMER. V. MUELLER SURGICALSTAPLES-CARTR
2
Cleared 510(K)
K
82
3552
APPOSE SKIN STAPLER & REMOVER
2
Cleared 510(K)
K
83
0199
AUTO SUTURE TA DISPOS-STAPLE CART
2
Cleared 510(K)
K
82
2345
DISPOSABLE LINEAR STAPLER (LSF)
2
Cleared 510(K)
K
82
1994
DISPOSABLE LINEAR STAPLER-(LSR)
2
Cleared 510(K)
K
81
0324
AUTOMATIC HEMOCLIP APPLIER, 527700
2
Cleared 510(K)
K
80
1154
PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.
2
Cleared 510(K)
K
78
0695
AUTO SUTURE DISPOSABLE STAPLING INSTRU.
2
Cleared 510(K)
K
78
0586
MICROCLIP, WILLIAMS
2
Cleared 510(K)
K
77
1178
DISP. LOADING UNIT, AUTO, SUTURE
2
Cleared 510(K)
K
76
1064
COVENTRY STAPLE
2
Cleared 510(K)
GDX
Scalpel, One-Piece
1
Product Code
GDY
Gauze/Sponge, Internal, X-Ray Detectable
1
Product Code
GDZ
Handle, Scalpel
1
Product Code
GEA
Cannula, Surgical, General & Plastic Surgery
1
Product Code
GEC
Brush, Scrub, Operating-Room
1
Product Code
GED
Brush, Dermabrasion, Manual
1
Product Code
GEE
Brush, Biopsy, General & Plastic Surgery
1
Product Code
GEF
Applier, Staple, Surgical,
1
Product Code
GEG
Elevator, Surgical, General & Plastic Surgery
1
Product Code
GEH
Unit, Cryosurgical, Accessories
2
Product Code
GEI
Electrosurgical, Cutting & Coagulation & Accessories
2
Product Code
GEJ
Carrier, Ligature
1
Product Code
GEN
Forceps, General & Plastic Surgery
1
Product Code
GEO
File, Surgical, General & Plastic Surgery
1
Product Code
GES
Blade, Scalpel
1
Product Code
GET
Motor, Surgical Instrument, Pneumatic Powered
1
Product Code
GEX
Powered Laser Surgical Instrument
2
Product Code
GEY
Motor, Surgical Instrument, Ac-Powered
1
Product Code
GFA
Blade, Saw, General & Plastic Surgery, Surgical
1
Product Code
GFB
Head, Surgical, Hammer
1
Product Code
GFC
Driver, Surgical, Pin
1
Product Code
GFD
Dermatome
1
Product Code
GFE
Brush, Dermabrasion, Powered
1
Product Code
GFF
Bur, Surgical, General & Plastic Surgery
1
Product Code
GFG
Bit, Surgical
1
Product Code
GFI
Osteotome, Manual
1
Product Code
GFJ
Mallet, Surgical, General & Plastic Surgery
1
Product Code
HAB
Saw, Powered, And Accessories
1
Product Code
HAM
Apparatus, Electrosurgical
2
Product Code
HBI
Illuminator, Fiberoptic, Surgical Field
2
Product Code
HBT
Applier, Hemostatic Clip
1
Product Code
HCF
Instrument, Ligature Passing And Knot Tying
1
Product Code
HJE
Lamp, Fluorescein, Ac-Powered
2
Product Code
HMP
Pad, Eye
1
Product Code
HRB
Microscope, Operating, Non-Electric, Ophthalmic
1
Product Code
HRM
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
1
Product Code
HRQ
Hemostat
1
Product Code
HSO
Saw
1
Product Code
HTC
Pliers, Surgical
1
Product Code
HTD
Forceps
1
Product Code
HTE
Elevator
1
Product Code
HTF
Curette
1
Product Code
HTR
Rasp
1
Product Code
HTZ
Instrument, Cutting, Orthopedic
1
Product Code
HWM
Osteotome
1
Product Code
HXD
Clamp
1
Product Code
HXL
Mallet
1
Product Code
HXR
Spatula, Orthopedic
1
Product Code
HXT
Tape, Orthopedic
1
Product Code
HYA
Forceps, Wire Holding
1
Product Code
JCX
Apparatus, Suction, Ward Use, Portable, Ac-Powered
2
Product Code
JCY
Catheter, Infusion
1
Product Code
JEA
Table, Surgical With Orthopedic Accessories, Ac-Powered
1
Product Code
JEB
Table, Surgical With Orthopedic Accessories, Manual
1
Product Code
JOS
Electrode, Electrosurgical
2
Product Code
JOT
Electrode, Gel, Electrosurgical
2
Product Code
JYC
Cannula, Ear
1
Product Code
JYD
Chisel, Mastoid
1
Product Code
KAM
Cannula, Sinus
1
Product Code
KAN
Chisel, Nasal
1
Product Code
KCE
Cannulae, Bronchial
1
Product Code
KDC
Instrument, Surgical, Disposable
1
Product Code
KDD
Kit, Surgical Instrument, Disposable
1
Product Code
KDG
Chisel (Osteotome)
1
Product Code
KFK
Saw, Pneumatically Powered
1
Product Code
KGL
Cabinet, Phototherapy (Puva)
2
Product Code
KGS
Retention Device, Suture
1
Product Code
KGW
Ring (Wound Protector), Drape Retention, Internal
2
Product Code
KGY
Bag, Intestine
1
Product Code
KGZ
Accessories, Catheter
1
Product Code
KIK
Hook, Bone
1
Product Code
KOX
Solvent, Adhesive Tape
1
Product Code
KOY
Degreaser, Skin, Surgical
1
Product Code
KOZ
Beads, Hydrophilic, For Wound Exudate Absorption
1
Product Code
KQM
Camera, Surgical And Accessories
1
Product Code
LEJ
Booth, Sun Tan
2
Product Code
LMF
Agent, Absorbable Hemostatic, Collagen Based
3
Product Code
LMG
Agent, Absorbable Hemostatic, Non-Collagen Based
3
Product Code
LRO
General Surgery Tray
2
Product Code
LRP
Tray, Surgical
1
Product Code
LRW
Scissors, General, Surgical
1
Product Code
LRY
Punch, Surgical
1
Product Code
LRZ
Screwdriver, Surgical
1
Product Code
LSA
Vise, Bench, Surgical
1
Product Code
LWG
Surgical Table Cushion
1
Product Code
LWK
Razor, Surgical
1
Product Code
LXK
Scrapper, Skin Specimen
1
Product Code
LXZ
Guard, Instrument
1
Product Code
LYV
Label Or Tag, Sterile
1
Product Code
LZM
Guard, Skin Graft
1
Product Code
MCH
Clip, Hemostatic
2
Product Code
MCZ
Suture Removal Kit
1
Product Code
MDA
Elastomer, Silicone, For Scar Management
1
Product Code
MDM
Instrument, Manual, Surgical, General Use
1
Product Code
MGO
Closure, Wound, Adhesive
1
Product Code
MIJ
Needle, Tumor Localization
1
Product Code
MJG
Device, Percutaneous, Biopsy
1
Product Code
MKY
System, Skin Closure
1
Product Code
MOQ
Battery, Replacement, Rechargeable
1
Product Code
MPN
Tissue Adhesive For The Topical Approximation Of Skin
2
Product Code
MUL
Generator, Electrosurgical, Coagulation, Cancer
2
Product Code
MUU
System, Suction, Lipoplasty
2
Product Code
MVR
Device, Anastomotic, Microvascular
2
Product Code
MWY
System, Microwave, Hair Removal
2
Product Code
MXG
Lamp, Uvc, (For Treating Skin And Wounds)
2
Product Code
MXW
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
2
Product Code
NAB
Gauze / Sponge,Nonresorbable For External Use
1
Product Code
NAC
Dressing, Wound, Hydrophilic
1
Product Code
NAD
Dressing, Wound, Occlusive
1
Product Code
NAE
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
1
Product Code
NBY
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
2
Product Code
NCA
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
2
Product Code
NEH
Anchor, Fascial
2
Product Code
NEU
Marker, Radiographic, Implantable
2
Product Code
NEW
Suture, Surgical, Absorbable, Polydioxanone
2
Product Code
NEY
System, Ablation, Microwave And Accessories
2
Product Code
NJC
Clip, Vas Deferens
2
Product Code
NJU
Suture, Nonabsorbable, Nitinol
2
Product Code
NJZ
Extractor, Vein
1
Product Code
NLK
Needle, Biopsy, Cardiovascular, Reprocessed
1
Product Code
NLL
Staple, Implantable, Reprocessed
2
Product Code
NMJ
Clip, Implantable, Reprocessed
2
Product Code
NMT
Needle, Catheter, Reprocessed
1
Product Code
NMU
Needle, Gastro-Urology, Reprocessed
1
Product Code
NNA
Biopsy Device, Percutaneous, Reprocessed
1
Product Code
NNC
Needle, Aspiration And Needle, Reprocessed
1
Product Code
NRB
Wound Cleaner, Ultrasound
2
Product Code
NRJ
Ultrasound, Skin Permeation
2
Product Code
NTB
System, Ablation, Ultrasound And Accessories
2
Product Code
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
2
Product Code
NUV
Massager, Vacuum, Light Induced Heating
2
Product Code
NVH
Suture, Knot, Mechanical
2
Product Code
NVJ
Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
2
Product Code
NWF
Drill, Battery Powered, Subungual Hematoma
1
Product Code
NWJ
Suture, Recombinant Technology
2
Product Code
NXF
Gas, Laser Generating
1
Product Code
NYS
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
2
Product Code
OAB
Low Energy Direct Current Thermal Ablation System
2
Product Code
ODR
Electrosurgical Patient Return Electrode
2
Product Code
OEI
Drainage Catheter With Antibiotic
2
Product Code
OEL
Laser, Benign Prostatic Hyperplasia
2
Product Code
OHO
First Aid Kit Without Drug
1
Product Code
OHS
Light Based Over The Counter Wrinkle Reduction
2
Product Code
OHT
Light Based Over-The-Counter Hair Removal
2
Product Code
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
2
Product Code
OJJ
Burn Kit Without Drug
1
Product Code
OJR
Vacuum Powered Body Fluid Collection Kit
2
Product Code
OJT
Aspiration Tray
1
Product Code
OJU
Skin Prep Tray
1
Product Code
OJV
Single Use Instrument Tray
1
Product Code
OUH
Skin Resurfacing Rf Applicator
2
Product Code
OUP
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
2
Product Code
OJW
Shave Prep Kit
2
Product Code
OKJ
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
2
Product Code
OKO
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
2
Product Code
OLP
Over-The-Counter Powered Light Based Laser For Acne
2
Product Code
OMD
Cutaneous Tissue Adhesive With Mesh
2
Product Code
OMP
Negative Pressure Wound Therapy Powered Suction Pump
2
Product Code
ONE
Powered Light Based Non-Laser Surgical Instrument
2
Product Code
ONF
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
2
Product Code
ONG
Powered Laser Surgical Instrument With Microbeam\Fractional Output
2
Product Code
ONQ
Electrosurgical Coagulation For Aesthetic
2
Product Code
OOK
Dermal Cooling Pack/Vacuum/Massager
2
Product Code
ORE
Cryogenic, Skin Tag Removal, Otc
2
Product Code
ORK
Laser Assisted Lipolysis
2
Product Code
OTK
Wound Drain Catheter System
2
Product Code
OUB
Instrument For Treatment Of Hyperhidrosis
2
Product Code
OVN
Suture Kit
2
Product Code
OXT
Percutaneous Surgical Set With Attachments
2
Product Code
OYW
Laser, Cellulite Appearance
2
Product Code
PAY
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
2
Product Code
PBX
Massager, Vacuum, Radio Frequency Induced Heat
2
Product Code
PBY
Temporary Tissue Marker
2
Product Code
PDG
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
2
Product Code
PDW
Internal Tissue Marker
2
Product Code
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
2
Product Code
PFP
Silicone Hydrogel For Scar Management
1
Product Code
PGZ
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
2
Product Code
PJK
Tissue Adhesive For Internal Use
3
Product Code
PKD
Laceration Tray
1
Product Code
PKE
Laparoscopic Cholecystectomy Kit
1
Product Code
PKO
Transparent Patch For Use In Treatment Of Tattoos
2
Product Code
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
2
Product Code
PMC
Scalp Cooling System
2
Product Code
PMX
Absorbable Collagen Hemostatic Agent With Thrombin
3
Product Code
PNL
Magnetic Surgical System
2
Product Code
POD
Temporary, Internal Use Hemostatic
2
Product Code
PQI
Wound Retraction And Protection System
2
Product Code
PSN
Light Based Imaging
2
Product Code
PTX
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
2
Product Code
PUI
Drape, Surgical, Exempt
2
Product Code
PXN
Basic Set-Up Tray
1
Product Code
PXO
Bone Marrow Biopsy Tray
1
Product Code
PXP
Breast Biopsy / Localization Tray
1
Product Code
QRL
Multiple Use Blood Lancet For Single Patient Use Only
2
Product Code
PXQ
Burn Dressing Tray
1
Product Code
PXR
Cement And Bone Removal Kit
1
Product Code
PXS
Cholecystectomy Kit
1
Product Code
PXU
Fluid Drainage Tray
1
Product Code
PXV
General Purpose Instrument Tray
1
Product Code
PXW
Herniorraphy Kit
1
Product Code
PXX
Incision Tray
1
Product Code
PXY
Irrigation Kit (Wounds)
1
Product Code
PXZ
Laparascopic Sphincterotomy Kit
1
Product Code
PYA
Liver Biopsy Kit
1
Product Code
PYB
Minor Surgical Procedures Tray
1
Product Code
PYC
Paracentesis Tray
1
Product Code
PYD
Pelviscopy Kit
1
Product Code
PYE
Staple Removal Kit
1
Product Code
PYF
Sterile Puncture Tray
1
Product Code
PYG
Suction Catheter Kit
1
Product Code
PYH
Surgical Retractor Kit
1
Product Code
PYI
Thoracic Catheter Insertion Tray
1
Product Code
PYJ
Ulcer Wound Tray
1
Product Code
PYK
Venous Ulcer Kit
1
Product Code
PYL
Wound Drainage Kit
1
Product Code
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
2
Product Code
PZQ
General Laparoscopic Power Morcellation Containment System
2
Product Code
QAI
Powered Microneedle Device
2
Product Code
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
2
Product Code
QCR
Wound Autofluorescence Imaging Device
2
Product Code
QCY
Laser Absorbing Particles
2
Product Code
QDF
Parathyroid Autofluorescence Detection Device
2
Product Code
QDG
Parathyroid Autofluorescence Imaging Device
2
Product Code
QRM
Multiple Use Blood Lancet For Multiple Patient Use
3
Product Code
QFC
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
2
Product Code
QHF
Energy Based Device For Treatment Of Tattoos
2
Product Code
QJF
Autofluorescence Imaging Adjunct Tool For Wounds
2
Product Code
QKL
Lipoaspirate Washing System For Aesthetic Body Contouring
2
Product Code
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
2
Product Code
QPB
System, Suction, Lipoplasty For Removal
2
Product Code
QPX
Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
2
Product Code
QPZ
Contact Cooling For Skin Lesion Pain Relief
2
Product Code
RAB
Sunlamp Products (Pre-Standard)
2
Product Code
REF
Suntan Bed
2
Product Code
REG
Suntan Lamp
2
Product Code
REH
Tabletop Sunlamp System
2
Product Code
QUB
Suction Lipoplasty System For Removal And Transfer
2
Product Code
QVJ
Low Power Electrosurgical Devices For Skin Lesion Destruction
2
Product Code
QZN
Multi-Photon Imaging
2
Product Code
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 3 January 2025 at 11:05 pm
SU
/
subpart-e—surgical-devices
/
GDW
/
K161757
View Source
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161757
510(k) Type
Traditional
Applicant
VICTOR MEDICAL INSTRUMENTS CO.,LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/5/2016
Days to Decision
161 days
Submission Type
Summary