HET · Class II · 21 CFR 884.1720

FDA Product Code HET: Laparoscope, Gynecologic (and Accessories)

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Ethicon, Inc. and Marlo Surgical Technology.

338
Total
338
Cleared
205d
Avg days
1977
Since
338 devices
97–120 of 338
Cleared Feb 22, 1996
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
K955456
Olympus America, Inc.
Obstetrics & Gynecology · 85d
Cleared Feb 16, 1996
TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
K942389
Hogan & Hartson
Obstetrics & Gynecology · 639d
Cleared Jan 11, 1996
R-MED ABDOMINAL WALL ELEVATOR
K953360
R-Med, Inc.
Obstetrics & Gynecology · 178d
Cleared Nov 17, 1995
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K943305
Olympus America, Inc.
Obstetrics & Gynecology · 497d
Cleared Nov 06, 1995
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 89d
Cleared Oct 31, 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838
Olympus America, Inc.
Obstetrics & Gynecology · 503d
Cleared Oct 20, 1995
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 224d
Cleared Oct 05, 1995
KSEA MODEL 203200 20 UNIMAT
K953190
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 87d
Cleared Sep 29, 1995
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
K953574
American Hydro-Surgical Instruments, Inc.
Obstetrics & Gynecology · 60d
Cleared Sep 28, 1995
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
K940265
Cook Urological, Inc.
Obstetrics & Gynecology · 615d
Cleared Sep 15, 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200
Olympus America, Inc.
Obstetrics & Gynecology · 382d
Cleared Sep 07, 1995
KARL STORZ SUCTION CATHETERS
K951250
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 171d
Cleared Aug 10, 1995
STRYKER OPERATING LAPAROSCOPE
K943100
Stryker Endoscopy
Obstetrics & Gynecology · 407d
Cleared Jul 20, 1995
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
K951394
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 114d
Cleared Jul 12, 1995
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K950962
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 132d
Cleared Jul 06, 1995
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
K946380
American Hydro-Surgical Instruments, Inc.
Obstetrics & Gynecology · 205d
Cleared Jun 14, 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951190
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared May 25, 1995
KSE STEINER ELECTROMECHANIC MORCELLATOR
K946147
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 160d
Cleared May 11, 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K946359
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 132d
Cleared May 05, 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 165d
Cleared May 05, 1995
CANNUAL AND TROCAR, SUPERPUBIC
K950457
Core Dynamics, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 25, 1995
AESCULAP LAPAROSCOPES
K942730
Aesculap, Inc.
Obstetrics & Gynecology · 320d
Cleared Mar 30, 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
K945211
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 156d
Cleared Mar 29, 1995
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
K943603
Aesculap, Inc.
Obstetrics & Gynecology · 247d