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
73–96 of 338
Cleared Mar 04, 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
K970105
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 50d
Cleared Feb 14, 1997
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
K960640
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Obstetrics & Gynecology · 368d
Cleared Feb 07, 1997
RIGID FIBER OPTIC LAPAROSCOPE
K962246
Health Care International Assoc.
Obstetrics & Gynecology · 241d
Cleared Jan 30, 1997
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
K964436
Western Surgical Instrument Co.
Obstetrics & Gynecology · 86d
Cleared Jan 29, 1997
KSEA PUNCTURE CANNULA
K964379
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 86d
Cleared Jan 17, 1997
FEMRX MORCELLATOR SYSTEM
K963872
Gynecare Innovation Center
Obstetrics & Gynecology · 113d
Cleared Jan 10, 1997
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
K964450
Pilling Weck Group
Obstetrics & Gynecology · 65d
Cleared Dec 20, 1996
KSEA UNIMAT PLUS
K963960
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 79d
Cleared Dec 19, 1996
KSEA UNIMAT PLUS
K963949
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 78d
Cleared Oct 28, 1996
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
K960299
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 280d
Cleared Oct 21, 1996
BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
K960810
Marlo Surgical Technology
Obstetrics & Gynecology · 236d
Cleared Sep 30, 1996
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
K962090
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 124d
Cleared Sep 24, 1996
INSUFFLATION NEEDLE
K963359
Applied Medical Resources
Obstetrics & Gynecology · 29d
Cleared Aug 29, 1996
A4907 LENS CLEANING SHEATH
K961860
Olympus America, Inc.
Obstetrics & Gynecology · 107d
Cleared Aug 09, 1996
RDP-2
K961922
Ranfac, Corp.
Obstetrics & Gynecology · 84d
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