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Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
2
Product Code
HET
Laparoscope, Gynecologic (And Accessories)
2
Product Code
K
22
1642
SIRIUS Endoscope System
2
Cleared 510(K)
K
21
0116
Video Endoscopy System, 3D Video Endoscopy System
2
Cleared 510(K)
K
20
1832
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
2
Cleared 510(K)
K
21
0104
SurroundScope System
2
Cleared 510(K)
K
20
1617
TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
2
Cleared 510(K)
K
20
0216
4K UHD Camera System
2
Cleared 510(K)
K
20
0638
LAP-iX Suction Irrigation
2
Cleared 510(K)
K
19
0190
WV1 Endoscope
2
Cleared 510(K)
K
19
0744
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
2
Cleared 510(K)
K
17
2796
Flex Robotic System and Flex Transabdominal Drive
2
Cleared 510(K)
K
17
3111
LAP-iX Suction Irrigation
2
Cleared 510(K)
K
16
3320
LAP-Pump PP110
2
Cleared 510(K)
K
15
0525
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
2
Cleared 510(K)
K
15
1011
VISERA 4K UHD SYSTEM
2
Cleared 510(K)
K
13
1656
MORCELLEX SIGMA GENERATOR
2
Cleared 510(K)
K
12
3365
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
2
Cleared 510(K)
K
11
1425
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
2
Cleared 510(K)
K
11
1788
ENDOEYE HD II
2
Cleared 510(K)
K
10
1458
LINA XCISE MODEL MOR-1515
2
Cleared 510(K)
K
09
1010
TROKAMED MORCELLATOR
2
Cleared 510(K)
K
10
0280
GYNCARE MORCELLEX TISSUE MORCELLATOR
2
Cleared 510(K)
K
08
0365
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
2
Cleared 510(K)
K
08
1173
ENDOSCOPIC CO2 REGULATION UNIT UCR
2
Cleared 510(K)
K
08
2451
STRYKER VIDEOSCOPE
2
Cleared 510(K)
K
08
0948
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
2
Cleared 510(K)
K
06
2097
VERESS CANNULA AND MODULAR VERESS CANNULA
2
Cleared 510(K)
K
06
2169
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
2
Cleared 510(K)
K
06
1268
G-LIX TISSUE GRASPER
2
Cleared 510(K)
K
06
1050
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
2
Cleared 510(K)
K
05
0404
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
04
3013
MILTEX LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
04
1321
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
2
Cleared 510(K)
K
04
0295
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
2
Cleared 510(K)
K
03
3177
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
2
Cleared 510(K)
K
02
1237
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
02
2384
XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
2
Cleared 510(K)
K
02
2748
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
2
Cleared 510(K)
K
02
0143
VASOVIEW 5 HARVESTING CANNULA
2
Cleared 510(K)
K
00
3805
GYNECOLOGICAL LAPAROSCOPES
2
Cleared 510(K)
K
01
0510
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
2
Cleared 510(K)
K
00
3417
MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
2
Cleared 510(K)
K
00
3164
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
2
Cleared 510(K)
K
99
3653
MICRO-FRANCE TROCARS AND ACCESSORIES
2
Cleared 510(K)
K
00
1220
ENDOPATH SURESEAL REDUCER CAP
2
Cleared 510(K)
K
00
0199
CORTEK MINI LAPAROSCOPE
2
Cleared 510(K)
K
99
2481
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
2
Cleared 510(K)
K
99
2513
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
2
Cleared 510(K)
K
99
3801
GYNECARE LAPAROSCOPIC MORCELLATOR
2
Cleared 510(K)
K
99
0372
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
2
Cleared 510(K)
K
99
2480
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
2
Cleared 510(K)
K
99
0732
LAP-WAVE 3000 (P07)
2
Cleared 510(K)
K
99
0004
DCI ENDOSCOPE
2
Cleared 510(K)
K
98
2276
BAHO AUTOCLAVABLE LAPAROSCOPE
2
Cleared 510(K)
K
98
2515
POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
2
Cleared 510(K)
K
98
2518
AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
2
Cleared 510(K)
K
98
2428
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
2
Cleared 510(K)
K
98
2149
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
2
Cleared 510(K)
K
98
1130
KSEA ENDO TIP SYSTEM
2
Cleared 510(K)
K
97
0712
LAPARO-TENSER
2
Cleared 510(K)
K
97
4763
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
2
Cleared 510(K)
K
97
0968
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
2
Cleared 510(K)
K
98
0694
KSEA PLASTIC TROCARS
2
Cleared 510(K)
K
97
2647
CO2 PNEUMO-DISSECTOR
2
Cleared 510(K)
K
98
0166
LIGHTSOURCE OR ILLUMINATOR
2
Cleared 510(K)
K
97
2488
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES
2
Cleared 510(K)
K
96
2985
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
2
Cleared 510(K)
K
97
3737
MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M
2
Cleared 510(K)
K
97
3304
MVM 3.3 MM MICROENDOSCOPE
2
Cleared 510(K)
K
97
1836
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
2
Cleared 510(K)
K
97
1896
GALILEO HIGH RESOLUTION MICRO COUPLER
2
Cleared 510(K)
K
97
1837
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
2
Cleared 510(K)
K
96
2777
AMR MINI-LAPAROSCOPE
2
Cleared 510(K)
K
97
1797
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
2
Cleared 510(K)
K
96
5045
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
2
Cleared 510(K)
K
97
1255
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
2
Cleared 510(K)
K
96
3076
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
2
Cleared 510(K)
K
96
5121
CANNULA
2
Cleared 510(K)
K
97
0151
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
96
5055
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
2
Cleared 510(K)
K
97
0105
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
2
Cleared 510(K)
K
96
0640
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
2
Cleared 510(K)
K
96
2246
RIGID FIBER OPTIC LAPAROSCOPE
2
Cleared 510(K)
K
96
4436
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
2
Cleared 510(K)
K
96
4379
KSEA PUNCTURE CANNULA
2
Cleared 510(K)
K
96
3872
FEMRX MORCELLATOR SYSTEM
2
Cleared 510(K)
K
96
4450
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
2
Cleared 510(K)
K
96
3960
KSEA UNIMAT PLUS
2
Cleared 510(K)
K
96
3949
KSEA UNIMAT PLUS
2
Cleared 510(K)
K
96
0299
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
2
Cleared 510(K)
K
96
0810
BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
2
Cleared 510(K)
K
96
2090
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
2
Cleared 510(K)
K
96
3359
INSUFFLATION NEEDLE
2
Cleared 510(K)
K
96
1860
A4907 LENS CLEANING SHEATH
2
Cleared 510(K)
K
96
1922
RDP-2
2
Cleared 510(K)
K
96
0936
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
2
Cleared 510(K)
K
96
0347
SAFETY TROCER WITH SPRINGLOADED OBDURATOR
2
Cleared 510(K)
K
95
4774
SHIELDED TROCAR (OBTURATOR)
2
Cleared 510(K)
K
95
0335
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
2
Cleared 510(K)
K
95
5412
A.S.D. SAFETY TROCAR
2
Cleared 510(K)
K
95
4775
FLO-STAT FLUID MONITORING SYSTEM
2
Cleared 510(K)
K
96
0262
CORING MORCELLATOR
2
Cleared 510(K)
K
95
1343
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
2
Cleared 510(K)
K
95
5403
OES LAPARO-THORACO VIDEOSCOPE TYPE V
2
Cleared 510(K)
K
95
5456
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
2
Cleared 510(K)
K
94
2389
TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
2
Cleared 510(K)
K
95
3360
R-MED ABDOMINAL WALL ELEVATOR
2
Cleared 510(K)
K
95
2889
INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS
2
Cleared 510(K)
K
95
3364
SPECULITE
2
Cleared 510(K)
K
94
3305
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
2
Cleared 510(K)
K
95
3809
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
2
Cleared 510(K)
K
94
2838
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
2
Cleared 510(K)
K
95
1105
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
2
Cleared 510(K)
K
95
4520
MICROSURGE VERESS NEEDLE
2
Cleared 510(K)
K
94
2431
LAPOROSCOPIC SCISSORS
2
Cleared 510(K)
K
95
3190
KSEA MODEL 203200 20 UNIMAT
2
Cleared 510(K)
K
95
3574
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
2
Cleared 510(K)
K
94
0265
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
2
Cleared 510(K)
K
95
3548
LAPAROSCOPIC SURGICAL INSTRUMENT
2
Cleared 510(K)
K
94
4200
HI-Q HAND INSTRUMENTS, OB/GYN USE
2
Cleared 510(K)
K
95
1250
KARL STORZ SUCTION CATHETERS
2
Cleared 510(K)
K
95
2508
FLOW-THERME, WISAP #7642
2
Cleared 510(K)
K
94
3100
STRYKER OPERATING LAPAROSCOPE
2
Cleared 510(K)
K
94
4270
CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS
2
Cleared 510(K)
K
94
1206
DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE
2
Cleared 510(K)
K
95
1394
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
2
Cleared 510(K)
K
95
0962
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
2
Cleared 510(K)
K
94
6380
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
2
Cleared 510(K)
K
94
3713
TORCARS,CANNULAE,SHEATHS,OBTURATORS
2
Cleared 510(K)
K
95
1190
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
2
Cleared 510(K)
K
95
1490
LASEVAC
2
Cleared 510(K)
K
94
6147
KSE STEINER ELECTROMECHANIC MORCELLATOR
2
Cleared 510(K)
K
94
3662
LAPARASCOPE
2
Cleared 510(K)
K
95
0108
R-MED MINI-RETRACTOR
2
Cleared 510(K)
K
94
6359
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
2
Cleared 510(K)
K
95
0457
CANNUAL AND TROCAR, SUPERPUBIC
2
Cleared 510(K)
K
94
5685
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
2
Cleared 510(K)
K
94
2730
AESCULAP LAPAROSCOPES
2
Cleared 510(K)
K
94
2411
R-MED DISPOSABLE PLUG
2
Cleared 510(K)
K
94
5211
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
2
Cleared 510(K)
K
94
3603
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
2
Cleared 510(K)
K
94
5982
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
2
Cleared 510(K)
K
94
3053
KSEA SEMM TISSUR PUNCH
2
Cleared 510(K)
K
93
2779
BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.
2
Cleared 510(K)
K
95
0232
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
2
Cleared 510(K)
K
94
1507
THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM
2
Cleared 510(K)
K
93
2387
CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
2
Cleared 510(K)
K
94
5741
TROCAR AND CANNULA ACCESSORY
2
Cleared 510(K)
K
93
2276
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
2
Cleared 510(K)
K
94
2973
HASSON STABILIZING ACCESS CANNULA (SAC)
2
Cleared 510(K)
K
94
6235
CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE
2
Cleared 510(K)
K
94
4268
CIT TWO WAY SUCTIN AND IRRIGATION TUBES
2
Cleared 510(K)
K
94
3810
IMAGYN MICROLAP INTRODUCER
2
Cleared 510(K)
K
94
5100
KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE
2
Cleared 510(K)
K
94
4269
CIT GRASPING AND DISSECTING FORCEPS
2
Cleared 510(K)
K
94
4079
IMAGYN MICROLAP(TM) LAPAROSCOPE
2
Cleared 510(K)
K
93
6273
STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360
2
Cleared 510(K)
K
94
4555
ENDOSCOPE
2
Cleared 510(K)
K
94
4563
FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS
2
Cleared 510(K)
K
93
4799
CONMED TROGARD
2
Cleared 510(K)
K
94
2447
HASSON OPEN LAPAROSCOPY CANNULA
2
Cleared 510(K)
K
93
1065
LAPAROVIEW
2
Cleared 510(K)
K
94
3508
INSUFFLATOR TUBING WITH FILTER
2
Cleared 510(K)
K
94
4245
DYNABITE LAPAROSCOPIC FORCEPS
2
Cleared 510(K)
K
94
4129
IMAGYN LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
94
3598
FLEXIBLE FIBER OPTIC LAPAROSCOPES
2
Cleared 510(K)
K
93
1478
ZEISS OPMI L STEREO-LAPAROSCOPE
2
Cleared 510(K)
K
93
6011
INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM
2
Cleared 510(K)
K
92
6259
SURGIMAT
2
Cleared 510(K)
K
92
5079
LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)
2
Cleared 510(K)
K
93
6071
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
2
Cleared 510(K)
K
94
1944
TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE
2
Cleared 510(K)
K
94
0718
INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS
2
Cleared 510(K)
K
92
1294
VIDEO ENDOSCOPE-RIGID MODIFICATION
2
Cleared 510(K)
K
92
6597
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
2
Cleared 510(K)
K
92
4611
IRRIGATION PUMP AND TUBING SET
2
Cleared 510(K)
K
93
3768
COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES
2
Cleared 510(K)
K
94
0505
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
2
Cleared 510(K)
K
94
1208
DIAGNOSTIC SLEEVE, REDUCER SLEEVE
2
Cleared 510(K)
K
94
1334
DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
2
Cleared 510(K)
K
92
6596
OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
2
Cleared 510(K)
K
92
3260
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
2
Cleared 510(K)
K
92
6594
OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES
2
Cleared 510(K)
K
94
0709
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
2
Cleared 510(K)
K
93
5785
KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES
2
Cleared 510(K)
K
94
1094
INSUFFLATION TUBING & FILTER
2
Cleared 510(K)
K
94
0462
HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION
2
Cleared 510(K)
K
94
0049
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS
2
Cleared 510(K)
K
94
0844
MYOMA DRILL 5MM-8383.611
2
Cleared 510(K)
K
92
1722
BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA
2
Cleared 510(K)
K
92
5968
ENDOSCOPE
2
Cleared 510(K)
K
93
5031
RIZA-RIBE NEEDLE
2
Cleared 510(K)
K
93
1771
BIRTCHER ENDOSCOPIC CORKSCREW
2
Cleared 510(K)
K
93
1654
BIRTCHER MAGNETIC RETRIEVER (GS-3100)
2
Cleared 510(K)
K
94
1494
ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS
2
Cleared 510(K)
K
93
2689
LAPRO-LOADER(TM)
2
Cleared 510(K)
K
92
3259
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS
2
Cleared 510(K)
K
92
6021
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE
2
Cleared 510(K)
K
93
3492
ESYS SYSTEM
2
Cleared 510(K)
K
93
4506
DYNABITE HYSTEROSCOPIC FORCEPS
2
Cleared 510(K)
K
93
4451
HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS
2
Cleared 510(K)
K
93
3698
100 SERIES ENDOSCOPIC GRASPING FORCEPS
2
Cleared 510(K)
K
93
3130
TROGARD TROCAR SLEEVE RETAINING THREAD
2
Cleared 510(K)
K
93
2118
ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
2
Cleared 510(K)
K
93
3008
RETRACTORS AND SCRAPER
2
Cleared 510(K)
K
93
0934
ENDOPATH RELOADABLE LINEAR CUTTER
2
Cleared 510(K)
K
91
5857
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
2
Cleared 510(K)
K
93
0756
LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE
2
Cleared 510(K)
K
92
4485
LAPAROSCOPY SET
2
Cleared 510(K)
K
93
2832
PRIMUS INSULATED FORCEPS
2
Cleared 510(K)
K
93
2634
NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES
2
Cleared 510(K)
K
92
2248
MALLAWANY ATRAUMATIC TISSUE FORCEPS
2
Cleared 510(K)
K
93
1561
TROCAR SLEEVE
2
Cleared 510(K)
K
92
1335
ULTRAFLOW SUCTION-IRRIGATION CANNULA
2
Cleared 510(K)
K
93
2072
JARIT SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
2020
ENTREE BLUNT TIP TROCAR AND ADAPTER
2
Cleared 510(K)
K
93
1501
NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
2
Cleared 510(K)
K
93
1136
APOLLO CAMERA
2
Cleared 510(K)
K
92
3568
TROCAR STABILITY THREAD
2
Cleared 510(K)
K
92
1716
DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
2
Cleared 510(K)
K
92
3636
TROCAR W/ BLUNT TIP OBTURATOR
2
Cleared 510(K)
K
92
4844
BULK TISSUE REMOVAL SYSTEM
2
Cleared 510(K)
K
92
3126
MALLAWANY TISSUE GRASPING FORCEPS
2
Cleared 510(K)
K
92
1417
URESIL LAPAROSCOPIC RETRACTOR
2
Cleared 510(K)
K
92
2418
VIDEO ENDOSCOPE SYSTEM
2
Cleared 510(K)
K
92
1015
SHARPE ENDOSPONGE ASPIIRATOR
2
Cleared 510(K)
K
91
5743
SHARPE ENDOTENACULUM
2
Cleared 510(K)
K
92
4530
CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI
2
Cleared 510(K)
K
92
0234
DAVOL LAPAROSCOPIC DISSECTORS
2
Cleared 510(K)
K
92
1888
SHARPE ENDODISSECTOR
2
Cleared 510(K)
K
91
5749
SHARPE ENDOLIGATURE CARRIER
2
Cleared 510(K)
K
91
5744
SHARPE ENDOHEMOSTAT
2
Cleared 510(K)
K
91
5747
SHARPE ENDOFORCEPS
2
Cleared 510(K)
K
91
5331
AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE
2
Cleared 510(K)
K
91
5338
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
2
Cleared 510(K)
K
92
0548
SHARPE ENDOSCALPEL
2
Cleared 510(K)
K
92
0549
SHARPE ENDONEEDLE HOLDER
2
Cleared 510(K)
K
91
4923
UNISURGE DISPOSABLE TROCAR
2
Cleared 510(K)
K
91
5378
WECK TROCAR
2
Cleared 510(K)
K
91
5116
TROCAR SHEATH ANCHOR
2
Cleared 510(K)
K
91
2093
DISPOSABLE ASPIRATION IRRIGATION SYSTEM
2
Cleared 510(K)
K
91
3944
NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES
2
Cleared 510(K)
K
91
3299
SOF-FLEX LAPAROSCOPIC BASKET
2
Cleared 510(K)
K
91
5297
TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM
2
Cleared 510(K)
K
90
3663
MEDSCOPE 8MM AND 10MM LAPAROSCOPE
2
Cleared 510(K)
K
91
4968
DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
2
Cleared 510(K)
K
91
2882
INNERVISION LAPAROSCOPE AND ACCESSORIES
2
Cleared 510(K)
K
91
2398
ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF
2
Cleared 510(K)
K
91
0921
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
2
Cleared 510(K)
K
91
0907
PUMP VAC PLUS
2
Cleared 510(K)
K
90
5471
TROCAR ACCESS SHEATH
2
Cleared 510(K)
K
91
0209
LAPAROSCOPIC IRRIGATOR/ASPIRATOR
2
Cleared 510(K)
K
90
4848
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
2
Cleared 510(K)
K
91
0015
CANNULA INTRODUCTION SET
2
Cleared 510(K)
K
91
0713
FLYNN TISSUE PROBE AND BLUNT DISSECTOR
2
Cleared 510(K)
K
91
0008
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
2
Cleared 510(K)
K
90
5759
HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS
2
Cleared 510(K)
K
90
3339
VIDEO ENDOSCOPE, RIGID
2
Cleared 510(K)
K
90
2197
FUJINON EVL-F (TENTATIVE) AND TROCAR
2
Cleared 510(K)
K
90
5196
LAPAROSCOPE
2
Cleared 510(K)
K
91
0579
OVARIAN ASPIRATION/IRRIGATION NEEDLE
2
Cleared 510(K)
K
91
0340
LAPAROSCOPIC ASPIRATION PROBE
2
Cleared 510(K)
K
90
4645
HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)
2
Cleared 510(K)
K
90
5426
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
2
Cleared 510(K)
K
90
4907
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
2
Cleared 510(K)
K
90
4379
SURGICAL TROCAR AND CANNULA
2
Cleared 510(K)
K
90
3078
HASSON STABILIZING ACCESS CANNULA
2
Cleared 510(K)
K
90
4173
INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS
2
Cleared 510(K)
K
90
4143
V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES
2
Cleared 510(K)
K
90
4142
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS
2
Cleared 510(K)
K
90
4104
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR
2
Cleared 510(K)
K
90
2722
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
2
Cleared 510(K)
K
90
3560
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
2
Cleared 510(K)
K
90
3780
AUTO SUTURE LAPAROSCOPY ACCESSORY KIT
2
Cleared 510(K)
K
90
3600
ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N
2
Cleared 510(K)
K
90
3598
ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N
2
Cleared 510(K)
K
90
3599
ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N
2
Cleared 510(K)
K
90
3206
AUTO SUTURE(R) ENDOSCOPIC SCISSORS
2
Cleared 510(K)
K
90
3187
LAPAROSCOPIC CATHERTER
2
Cleared 510(K)
K
90
3124
LAPAROSCOPIC ACCESS SHEATH SET
2
Cleared 510(K)
K
90
3207
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
2
Cleared 510(K)
K
90
2657
GYNESCOPE LAPAROSCOPIC FORCEPS
2
Cleared 510(K)
K
90
2258
5 MM IRRIGATION/ASPIRATION FIBER PROBE
2
Cleared 510(K)
K
90
3601
ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204
2
Cleared 510(K)
K
90
3602
ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203
2
Cleared 510(K)
K
90
3597
ESPI MICRO SCISSORS, #8150
2
Cleared 510(K)
K
90
3596
ESPI REDUCER SLEEVE, #8415
2
Cleared 510(K)
K
90
3595
ESPI CLAW FORCEP, #8302, 10MM, 30CM
2
Cleared 510(K)
K
90
3594
ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201
2
Cleared 510(K)
K
90
3593
ESPI APPLICATOR SLEEVE, #8410
2
Cleared 510(K)
K
90
3592
ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH
2
Cleared 510(K)
K
90
3591
ESPI HOOK/UNIVERSAL SCISSORS, # 8101
2
Cleared 510(K)
K
89
6524
SPIRTOS COAXIAL CATHETER SET
2
Cleared 510(K)
K
90
3528
LAPAROSCOPE
2
Cleared 510(K)
K
90
2563
MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
2
Cleared 510(K)
K
90
2655
GYNESCOPE LAPAROSCOPES
2
Cleared 510(K)
K
90
2656
GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES
2
Cleared 510(K)
K
90
1407
CORE DISPOSABLE TROCARS
2
Cleared 510(K)
K
90
0988
AMCATH SUCTION-IRRIGATION TUBE
2
Cleared 510(K)
K
89
6118
NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
2
Cleared 510(K)
K
89
5225
GYNECOLOGICAL INSTRUMENTATION
2
Cleared 510(K)
K
89
7064
LAPAROSCOPIC ACCESS SHEATH SET
2
Cleared 510(K)
K
89
3715
ETHICON DISPOSABLE SURGICAL TROCAR
2
Cleared 510(K)
K
88
4781
OPTI-POINT
2
Cleared 510(K)
K
87
4611
TITANIUM BACKSTOP WITH SUCTION
2
Cleared 510(K)
K
87
4614
SUCTION AND LAVAGE PROBE
2
Cleared 510(K)
K
87
4612
TITANIUM RODS
2
Cleared 510(K)
K
88
0763
NEZHAT IRRIGATION PUMP SYSTEM
2
Cleared 510(K)
K
88
1010
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
2
Cleared 510(K)
K
87
3115
CABOT FIBER LASER PROBE
2
Cleared 510(K)
K
87
3598
LASER LAPAROSCOPY SET
2
Cleared 510(K)
K
86
0192
ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE
2
Cleared 510(K)
K
85
2680
TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG
2
Cleared 510(K)
K
85
2901
DOUBLE PUNCTURE INSTRUMENTS
2
Cleared 510(K)
K
85
2031
ENDOPORT 5MM
2
Cleared 510(K)
K
84
2498
DANIELL DBL PUNCTURE LASER LAPAROSCOPY
2
Cleared 510(K)
K
83
1241
LASER LAPARAXOPE
2
Cleared 510(K)
K
82
3294
MEDIGROUP LS-110 LIGHT SOURCE
2
Cleared 510(K)
K
82
3297
ST-610 NEEDLESCOPE STERILIZATION TRAY
2
Cleared 510(K)
K
82
3295
MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&
2
Cleared 510(K)
K
82
3293
MEDIGROUP LG-102 LIGHT GUIDE
2
Cleared 510(K)
K
81
3133
KEYMED KEY LIGHT
2
Cleared 510(K)
K
81
2199
TROCAR & TROCAR SLEEVES
2
Cleared 510(K)
K
81
2206
LAPAROSCOPE
2
Cleared 510(K)
K
80
0668
CANNULA, W/SHARP OBTURATOR & VERESS NEED
2
Cleared 510(K)
K
79
1052
ENDOSCOPIC INSTRUMENT
2
Cleared 510(K)
K
77
2242
LAPAROSCOPY CONSOLE MODEL VIII
2
Cleared 510(K)
K
77
2185
LAPAROSCOPE W/REMOVABLE OPTICS
2
Cleared 510(K)
K
77
1962
CAMERA ADAPTER FOR ENDOSCOPES
2
Cleared 510(K)
K
77
1961
DUAL INCISION TUBAL OCCLUS. BAND APPLI.
2
Cleared 510(K)
K
77
1958
12MM SELF-SEALING TROCAR & CANNULA
2
Cleared 510(K)
K
77
1959
8MM SELF-SEALING TROCAR & CANNULA
2
Cleared 510(K)
K
77
1964
8MM TROCAR & CANNUAL W/STOPCOCK
2
Cleared 510(K)
K
77
1963
SINGLE INCISION TUBAL OCCLU. BAND APPL.
2
Cleared 510(K)
K
77
1960
TUBAL OCCLUSION INSERTER/LAPAROSCOPE
2
Cleared 510(K)
K
77
0378
LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS
2
Cleared 510(K)
K
77
0379
TROCAR SLEEVE SYSTEM
2
Cleared 510(K)
HEW
Culdoscope (And Accessories)
2
Product Code
HEX
Colposcope (And Colpomicroscope)
2
Product Code
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
2
Product Code
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
F
Product Code
HFC
Aspirator, Endocervical
2
Product Code
HFD
Washer, Endometrial
2
Product Code
HFE
Brush, Endometrial
2
Product Code
HFF
Aspirator, Endometrial
2
Product Code
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
2
Product Code
HGW
Sampler, Blood, Fetal
2
Product Code
HHK
Curette, Suction, Endometrial (And Accessories)
2
Product Code
HIF
Insufflator, Laparoscopic
2
Product Code
HIG
Insufflator, Hysteroscopic
2
Product Code
HIH
Hysteroscope (And Accessories)
2
Product Code
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
1
Product Code
LHZ
Viscometer, Mucus, Cervical
1
Product Code
MKO
Falloposcope
2
Product Code
MOK
Vaginoscope And Accessories
2
Product Code
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
1
Product Code
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
2
Product Code
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
1
Product Code
NVT
Tubing And Tubing/Filter Fits
1
Product Code
NWV
Laparoscopic Accessories, Gynecologic
1
Product Code
NWW
Hysteroscope Accessories
1
Product Code
PCF
Sampler, Endocervical
2
Product Code
OHD
Gynecological Laparoscopic Kit
2
Product Code
OHE
Forensic Evidence Sexual Assault Kit
2
Product Code
OHF
Culdocentesis Kit
2
Product Code
OHM
Cesarean Section Tray
2
Product Code
OKX
Trocar Kit
2
Product Code
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
2
Product Code
OKZ
Endometrial Sampling Kit
2
Product Code
OSV
Insufflator, Endoscopic Vessel Harvesting
2
Product Code
PTZ
Colposcope (And Colpomicroscope), Exempt
2
Product Code
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
2
Product Code
QHZ
Seal, Cervical, Mechanical, Unpowered
1
Product Code
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
OB
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
HET
/
K914968
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DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K914968
510(k) Type
Traditional
Applicant
ETHICON, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/1992
Days to Decision
90 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
HET
Laparoscope, Gynecologic (And Accessories)
K
22
1642
SIRIUS Endoscope System
K
21
0116
Video Endoscopy System, 3D Video Endoscopy System
K
20
1832
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
K
21
0104
SurroundScope System
K
20
1617
TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
K
20
0216
4K UHD Camera System
K
20
0638
LAP-iX Suction Irrigation
K
19
0190
WV1 Endoscope
K
19
0744
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
K
17
2796
Flex Robotic System and Flex Transabdominal Drive
K
17
3111
LAP-iX Suction Irrigation
K
16
3320
LAP-Pump PP110
K
15
0525
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
K
15
1011
VISERA 4K UHD SYSTEM
K
13
1656
MORCELLEX SIGMA GENERATOR
K
12
3365
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
K
11
1425
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
K
11
1788
ENDOEYE HD II
K
10
1458
LINA XCISE MODEL MOR-1515
K
09
1010
TROKAMED MORCELLATOR
K
10
0280
GYNCARE MORCELLEX TISSUE MORCELLATOR
K
08
0365
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
K
08
1173
ENDOSCOPIC CO2 REGULATION UNIT UCR
K
08
2451
STRYKER VIDEOSCOPE
K
08
0948
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K
06
2097
VERESS CANNULA AND MODULAR VERESS CANNULA
K
06
2169
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
K
06
1268
G-LIX TISSUE GRASPER
K
06
1050
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
K
05
0404
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K
04
3013
MILTEX LAPAROSCOPIC INSTRUMENTS
K
04
1321
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K
04
0295
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K
03
3177
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
K
02
1237
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K
02
2384
XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
K
02
2748
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
K
02
0143
VASOVIEW 5 HARVESTING CANNULA
K
00
3805
GYNECOLOGICAL LAPAROSCOPES
K
01
0510
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
K
00
3417
MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
K
00
3164
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K
99
3653
MICRO-FRANCE TROCARS AND ACCESSORIES
K
00
1220
ENDOPATH SURESEAL REDUCER CAP
K
00
0199
CORTEK MINI LAPAROSCOPE
K
99
2481
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
K
99
2513
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
K
99
3801
GYNECARE LAPAROSCOPIC MORCELLATOR
K
99
0372
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
K
99
2480
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
K
99
0732
LAP-WAVE 3000 (P07)
K
99
0004
DCI ENDOSCOPE
K
98
2276
BAHO AUTOCLAVABLE LAPAROSCOPE
K
98
2515
POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
K
98
2518
AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
K
98
2428
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
K
98
2149
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K
98
1130
KSEA ENDO TIP SYSTEM
K
97
0712
LAPARO-TENSER
K
97
4763
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K
97
0968
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
K
98
0694
KSEA PLASTIC TROCARS
K
97
2647
CO2 PNEUMO-DISSECTOR
K
98
0166
LIGHTSOURCE OR ILLUMINATOR
K
97
2488
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES
K
96
2985
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
K
97
3737
MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M
K
97
3304
MVM 3.3 MM MICROENDOSCOPE
K
97
1836
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
K
97
1896
GALILEO HIGH RESOLUTION MICRO COUPLER
K
97
1837
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
K
96
2777
AMR MINI-LAPAROSCOPE
K
97
1797
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
K
96
5045
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
K
97
1255
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
K
96
3076
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
K
96
5121
CANNULA
K
97
0151
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K
96
5055
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
K
97
0105
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
K
96
0640
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
K
96
2246
RIGID FIBER OPTIC LAPAROSCOPE
K
96
4436
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
K
96
4379
KSEA PUNCTURE CANNULA
K
96
3872
FEMRX MORCELLATOR SYSTEM
K
96
4450
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
K
96
3960
KSEA UNIMAT PLUS
K
96
3949
KSEA UNIMAT PLUS
K
96
0299
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
K
96
0810
BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
K
96
2090
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
K
96
3359
INSUFFLATION NEEDLE
K
96
1860
A4907 LENS CLEANING SHEATH
K
96
1922
RDP-2
K
96
0936
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
K
96
0347
SAFETY TROCER WITH SPRINGLOADED OBDURATOR
K
95
4774
SHIELDED TROCAR (OBTURATOR)
K
95
0335
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K
95
5412
A.S.D. SAFETY TROCAR
K
95
4775
FLO-STAT FLUID MONITORING SYSTEM
K
96
0262
CORING MORCELLATOR
K
95
1343
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K
95
5403
OES LAPARO-THORACO VIDEOSCOPE TYPE V
K
95
5456
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
K
94
2389
TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
K
95
3360
R-MED ABDOMINAL WALL ELEVATOR
K
95
2889
INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS
K
95
3364
SPECULITE
K
94
3305
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K
95
3809
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K
94
2838
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K
95
1105
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K
95
4520
MICROSURGE VERESS NEEDLE
K
94
2431
LAPOROSCOPIC SCISSORS
K
95
3190
KSEA MODEL 203200 20 UNIMAT
K
95
3574
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
K
94
0265
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
K
95
3548
LAPAROSCOPIC SURGICAL INSTRUMENT
K
94
4200
HI-Q HAND INSTRUMENTS, OB/GYN USE
K
95
1250
KARL STORZ SUCTION CATHETERS
K
95
2508
FLOW-THERME, WISAP #7642
K
94
3100
STRYKER OPERATING LAPAROSCOPE
K
94
4270
CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS
K
94
1206
DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE
K
95
1394
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
K
95
0962
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K
94
6380
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
K
94
3713
TORCARS,CANNULAE,SHEATHS,OBTURATORS
K
95
1190
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K
95
1490
LASEVAC
K
94
6147
KSE STEINER ELECTROMECHANIC MORCELLATOR
K
94
3662
LAPARASCOPE
K
95
0108
R-MED MINI-RETRACTOR
K
94
6359
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K
95
0457
CANNUAL AND TROCAR, SUPERPUBIC
K
94
5685
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K
94
2730
AESCULAP LAPAROSCOPES
K
94
2411
R-MED DISPOSABLE PLUG
K
94
5211
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
K
94
3603
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
K
94
5982
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K
94
3053
KSEA SEMM TISSUR PUNCH
K
93
2779
BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.
K
95
0232
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
K
94
1507
THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM
K
93
2387
CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
K
94
5741
TROCAR AND CANNULA ACCESSORY
K
93
2276
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
K
94
2973
HASSON STABILIZING ACCESS CANNULA (SAC)
K
94
6235
CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE
K
94
4268
CIT TWO WAY SUCTIN AND IRRIGATION TUBES
K
94
3810
IMAGYN MICROLAP INTRODUCER
K
94
5100
KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE
K
94
4269
CIT GRASPING AND DISSECTING FORCEPS
K
94
4079
IMAGYN MICROLAP(TM) LAPAROSCOPE
K
93
6273
STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360
K
94
4555
ENDOSCOPE
K
94
4563
FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS
K
93
4799
CONMED TROGARD
K
94
2447
HASSON OPEN LAPAROSCOPY CANNULA
K
93
1065
LAPAROVIEW
K
94
3508
INSUFFLATOR TUBING WITH FILTER
K
94
4245
DYNABITE LAPAROSCOPIC FORCEPS
K
94
4129
IMAGYN LAPAROSCOPIC INSTRUMENTS
K
94
3598
FLEXIBLE FIBER OPTIC LAPAROSCOPES
K
93
1478
ZEISS OPMI L STEREO-LAPAROSCOPE
K
93
6011
INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM
K
92
6259
SURGIMAT
K
92
5079
LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)
K
93
6071
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K
94
1944
TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE
K
94
0718
INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS
K
92
1294
VIDEO ENDOSCOPE-RIGID MODIFICATION
K
92
6597
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
K
92
4611
IRRIGATION PUMP AND TUBING SET
K
93
3768
COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES
K
94
0505
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
K
94
1208
DIAGNOSTIC SLEEVE, REDUCER SLEEVE
K
94
1334
DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
K
92
6596
OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
K
92
3260
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
K
92
6594
OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES
K
94
0709
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
K
93
5785
KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES
K
94
1094
INSUFFLATION TUBING & FILTER
K
94
0462
HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION
K
94
0049
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS
K
94
0844
MYOMA DRILL 5MM-8383.611
K
92
1722
BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA
K
92
5968
ENDOSCOPE
K
93
5031
RIZA-RIBE NEEDLE
K
93
1771
BIRTCHER ENDOSCOPIC CORKSCREW
K
93
1654
BIRTCHER MAGNETIC RETRIEVER (GS-3100)
K
94
1494
ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS
K
93
2689
LAPRO-LOADER(TM)
K
92
3259
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS
K
92
6021
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE
K
93
3492
ESYS SYSTEM
K
93
4506
DYNABITE HYSTEROSCOPIC FORCEPS
K
93
4451
HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS
K
93
3698
100 SERIES ENDOSCOPIC GRASPING FORCEPS
K
93
3130
TROGARD TROCAR SLEEVE RETAINING THREAD
K
93
2118
ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
K
93
3008
RETRACTORS AND SCRAPER
K
93
0934
ENDOPATH RELOADABLE LINEAR CUTTER
K
91
5857
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
K
93
0756
LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE
K
92
4485
LAPAROSCOPY SET
K
93
2832
PRIMUS INSULATED FORCEPS
K
93
2634
NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES
K
92
2248
MALLAWANY ATRAUMATIC TISSUE FORCEPS
K
93
1561
TROCAR SLEEVE
K
92
1335
ULTRAFLOW SUCTION-IRRIGATION CANNULA
K
93
2072
JARIT SURGICAL INSTRUMENTS
K
93
2020
ENTREE BLUNT TIP TROCAR AND ADAPTER
K
93
1501
NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
K
93
1136
APOLLO CAMERA
K
92
3568
TROCAR STABILITY THREAD
K
92
1716
DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
K
92
3636
TROCAR W/ BLUNT TIP OBTURATOR
K
92
4844
BULK TISSUE REMOVAL SYSTEM
K
92
3126
MALLAWANY TISSUE GRASPING FORCEPS
K
92
1417
URESIL LAPAROSCOPIC RETRACTOR
K
92
2418
VIDEO ENDOSCOPE SYSTEM
K
92
1015
SHARPE ENDOSPONGE ASPIIRATOR
K
91
5743
SHARPE ENDOTENACULUM
K
92
4530
CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI
K
92
0234
DAVOL LAPAROSCOPIC DISSECTORS
K
92
1888
SHARPE ENDODISSECTOR
K
91
5749
SHARPE ENDOLIGATURE CARRIER
K
91
5744
SHARPE ENDOHEMOSTAT
K
91
5747
SHARPE ENDOFORCEPS
K
91
5331
AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE
K
91
5338
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
K
92
0548
SHARPE ENDOSCALPEL
K
92
0549
SHARPE ENDONEEDLE HOLDER
K
91
4923
UNISURGE DISPOSABLE TROCAR
K
91
5378
WECK TROCAR
K
91
5116
TROCAR SHEATH ANCHOR
K
91
2093
DISPOSABLE ASPIRATION IRRIGATION SYSTEM
K
91
3944
NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES
K
91
3299
SOF-FLEX LAPAROSCOPIC BASKET
K
91
5297
TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM
K
90
3663
MEDSCOPE 8MM AND 10MM LAPAROSCOPE
K
91
4968
DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
K
91
2882
INNERVISION LAPAROSCOPE AND ACCESSORIES
K
91
2398
ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF
K
91
0921
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
K
91
0907
PUMP VAC PLUS
K
90
5471
TROCAR ACCESS SHEATH
K
91
0209
LAPAROSCOPIC IRRIGATOR/ASPIRATOR
K
90
4848
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
K
91
0015
CANNULA INTRODUCTION SET
K
91
0713
FLYNN TISSUE PROBE AND BLUNT DISSECTOR
K
91
0008
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
K
90
5759
HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS
K
90
3339
VIDEO ENDOSCOPE, RIGID
K
90
2197
FUJINON EVL-F (TENTATIVE) AND TROCAR
K
90
5196
LAPAROSCOPE
K
91
0579
OVARIAN ASPIRATION/IRRIGATION NEEDLE
K
91
0340
LAPAROSCOPIC ASPIRATION PROBE
K
90
4645
HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)
K
90
5426
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
K
90
4907
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER
K
90
4379
SURGICAL TROCAR AND CANNULA
K
90
3078
HASSON STABILIZING ACCESS CANNULA
K
90
4173
INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS
K
90
4143
V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES
K
90
4142
GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS
K
90
4104
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR
K
90
2722
BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
K
90
3560
CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
K
90
3780
AUTO SUTURE LAPAROSCOPY ACCESSORY KIT
K
90
3600
ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N
K
90
3598
ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N
K
90
3599
ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N
K
90
3206
AUTO SUTURE(R) ENDOSCOPIC SCISSORS
K
90
3187
LAPAROSCOPIC CATHERTER
K
90
3124
LAPAROSCOPIC ACCESS SHEATH SET
K
90
3207
AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE
K
90
2657
GYNESCOPE LAPAROSCOPIC FORCEPS
K
90
2258
5 MM IRRIGATION/ASPIRATION FIBER PROBE
K
90
3601
ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204
K
90
3602
ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203
K
90
3597
ESPI MICRO SCISSORS, #8150
K
90
3596
ESPI REDUCER SLEEVE, #8415
K
90
3595
ESPI CLAW FORCEP, #8302, 10MM, 30CM
K
90
3594
ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201
K
90
3593
ESPI APPLICATOR SLEEVE, #8410
K
90
3592
ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH
K
90
3591
ESPI HOOK/UNIVERSAL SCISSORS, # 8101
K
89
6524
SPIRTOS COAXIAL CATHETER SET
K
90
3528
LAPAROSCOPE
K
90
2563
MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
K
90
2655
GYNESCOPE LAPAROSCOPES
K
90
2656
GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES
K
90
1407
CORE DISPOSABLE TROCARS
K
90
0988
AMCATH SUCTION-IRRIGATION TUBE
K
89
6118
NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE
K
89
5225
GYNECOLOGICAL INSTRUMENTATION
K
89
7064
LAPAROSCOPIC ACCESS SHEATH SET
K
89
3715
ETHICON DISPOSABLE SURGICAL TROCAR
K
88
4781
OPTI-POINT
K
87
4611
TITANIUM BACKSTOP WITH SUCTION
K
87
4614
SUCTION AND LAVAGE PROBE
K
87
4612
TITANIUM RODS
K
88
0763
NEZHAT IRRIGATION PUMP SYSTEM
K
88
1010
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K
87
3115
CABOT FIBER LASER PROBE
K
87
3598
LASER LAPAROSCOPY SET
K
86
0192
ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE
K
85
2680
TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG
K
85
2901
DOUBLE PUNCTURE INSTRUMENTS
K
85
2031
ENDOPORT 5MM
K
84
2498
DANIELL DBL PUNCTURE LASER LAPAROSCOPY
K
83
1241
LASER LAPARAXOPE
K
82
3294
MEDIGROUP LS-110 LIGHT SOURCE
K
82
3297
ST-610 NEEDLESCOPE STERILIZATION TRAY
K
82
3295
MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&
K
82
3293
MEDIGROUP LG-102 LIGHT GUIDE
K
81
3133
KEYMED KEY LIGHT
K
81
2199
TROCAR & TROCAR SLEEVES
K
81
2206
LAPAROSCOPE
K
80
0668
CANNULA, W/SHARP OBTURATOR & VERESS NEED
K
79
1052
ENDOSCOPIC INSTRUMENT
K
77
2242
LAPAROSCOPY CONSOLE MODEL VIII
K
77
2185
LAPAROSCOPE W/REMOVABLE OPTICS
K
77
1962
CAMERA ADAPTER FOR ENDOSCOPES
K
77
1961
DUAL INCISION TUBAL OCCLUS. BAND APPLI.
K
77
1958
12MM SELF-SEALING TROCAR & CANNULA
K
77
1959
8MM SELF-SEALING TROCAR & CANNULA
K
77
1964
8MM TROCAR & CANNUAL W/STOPCOCK
K
77
1963
SINGLE INCISION TUBAL OCCLU. BAND APPL.
K
77
1960
TUBAL OCCLUSION INSERTER/LAPAROSCOPE
K
77
0378
LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS
K
77
0379
TROCAR SLEEVE SYSTEM
HEW
Culdoscope (And Accessories)
HEX
Colposcope (And Colpomicroscope)
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
HFC
Aspirator, Endocervical
HFD
Washer, Endometrial
HFE
Brush, Endometrial
HFF
Aspirator, Endometrial
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
HGW
Sampler, Blood, Fetal
HHK
Curette, Suction, Endometrial (And Accessories)
HIF
Insufflator, Laparoscopic
HIG
Insufflator, Hysteroscopic
HIH
Hysteroscope (And Accessories)
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
LHZ
Viscometer, Mucus, Cervical
MKO
Falloposcope
MOK
Vaginoscope And Accessories
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
NVT
Tubing And Tubing/Filter Fits
NWV
Laparoscopic Accessories, Gynecologic
NWW
Hysteroscope Accessories
PCF
Sampler, Endocervical
OHD
Gynecological Laparoscopic Kit
OHE
Forensic Evidence Sexual Assault Kit
OHF
Culdocentesis Kit
OHM
Cesarean Section Tray
OKX
Trocar Kit
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
OKZ
Endometrial Sampling Kit
OSV
Insufflator, Endoscopic Vessel Harvesting
PTZ
Colposcope (And Colpomicroscope), Exempt
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
QHZ
Seal, Cervical, Mechanical, Unpowered
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
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subpart-b—obstetrical-and-gynecological-diagnostic-devices
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HET
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K914968
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DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K914968
510(k) Type
Traditional
Applicant
ETHICON, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/1992
Days to Decision
90 days
Submission Type
Statement