HET · Class II · 21 CFR 884.1720

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

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Dixon Medical, Inc. and Ethicon, Inc..

338
Total
338
Cleared
205d
Avg days
1977
Since
338 devices
97–120 of 338
Cleared Jul 24, 1996
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
K960936
Origin Medsystems, Inc.
Obstetrics & Gynecology · 138d
Cleared Jul 01, 1996
SAFETY TROCER WITH SPRINGLOADED OBDURATOR
K960347
Spiess Design, Inc.
Obstetrics & Gynecology · 158d
Cleared Jun 07, 1996
SHIELDED TROCAR (OBTURATOR)
K954774
Gabris Surgical Corp.
Obstetrics & Gynecology · 234d
Cleared May 16, 1996
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 475d
Cleared May 14, 1996
A.S.D. SAFETY TROCAR
K955412
American Surgical Devices
Obstetrics & Gynecology · 169d
Cleared May 10, 1996
FLO-STAT FLUID MONITORING SYSTEM
K954775
Gynecare Innovation Center
Obstetrics & Gynecology · 206d
Cleared Apr 15, 1996
CORING MORCELLATOR
K960262
Cook Urological, Inc.
Obstetrics & Gynecology · 88d
Cleared Apr 11, 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 384d
Cleared Mar 11, 1996
OES LAPARO-THORACO VIDEOSCOPE TYPE V
K955403
Olympus America, Inc.
Obstetrics & Gynecology · 105d
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 Dec 22, 1995
INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS
K952889
Materials Conversion Corp.
Obstetrics & Gynecology · 182d
Cleared Dec 08, 1995
SPECULITE
K953364
Trylon Corp.
Obstetrics & Gynecology · 144d
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 16, 1995
MICROSURGE VERESS NEEDLE
K954520
Microsurge, Inc.
Obstetrics & Gynecology · 18d
Cleared Oct 11, 1995
LAPOROSCOPIC SCISSORS
K942431
Enterprise Medical Corp.
Obstetrics & Gynecology · 509d
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 19, 1995
LAPAROSCOPIC SURGICAL INSTRUMENT
K953548
Gabris Surgical Corp.
Obstetrics & Gynecology · 53d