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 United States Surgical, A Division of Tyco Healthc.

338
Total
338
Cleared
205d
Avg days
1977
Since
338 devices
25–48 of 338
Cleared Jul 14, 2006
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
K061050
Ethicon, Inc.
Obstetrics & Gynecology · 88d
Cleared Apr 21, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050404
Intuitive Surgical, Inc.
Obstetrics & Gynecology · 63d
Cleared Jul 09, 2004
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K041321
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 52d
Cleared Mar 12, 2004
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295
Applied Medical Resources Corp.
Obstetrics & Gynecology · 32d
Cleared Apr 10, 2003
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237
CooperSurgical, Inc.
Obstetrics & Gynecology · 357d
Cleared Apr 04, 2001
MINI FIBER ENDOSCOPES
K003417
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 153d
Cleared Jan 08, 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 90d
Cleared Jun 09, 2000
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653
Xomed, Inc.
Obstetrics & Gynecology · 224d
Cleared May 16, 2000
ENDOPATH SURESEAL REDUCER CAP
K001220
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 29d
Cleared Feb 07, 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801
Ethicon, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 02, 1999
DCI ENDOSCOPE
K990004
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 88d
Cleared Sep 10, 1998
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149
Smith & Nephew, Inc.
Obstetrics & Gynecology · 84d
Cleared Aug 19, 1998
KSEA ENDO TIP SYSTEM
K981130
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 142d
Cleared Jul 10, 1998
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K974763
Deroyal Industries, Inc.
Obstetrics & Gynecology · 203d
Cleared May 08, 1998
KSEA PLASTIC TROCARS
K980694
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 74d
Cleared Apr 10, 1998
CO2 PNEUMO-DISSECTOR
K972647
Cook Urological, Inc.
Obstetrics & Gynecology · 269d
Cleared Jan 22, 1998
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES
K972488
Karl Storz Endoscopy
Obstetrics & Gynecology · 204d
Cleared Dec 19, 1997
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
K962985
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 505d
Cleared Dec 12, 1997
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
K973737
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 73d
Cleared Dec 02, 1997
MVM 3.3 MM MICROENDOSCOPE
K973304
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Nov 07, 1997
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
K971836
CooperSurgical, Inc.
Obstetrics & Gynecology · 172d
Cleared Aug 06, 1997
AMR MINI-LAPAROSCOPE
K962777
Applied Medical Resources
Obstetrics & Gynecology · 385d
Cleared Aug 06, 1997
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
K971837
CooperSurgical, Inc.
Obstetrics & Gynecology · 79d
Cleared May 05, 1997
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
K965045
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 139d