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
25–48 of 338
Cleared Sep 26, 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 176d
Cleared Oct 13, 2006
VERESS CANNULA AND MODULAR VERESS CANNULA
K062097
PAJUNK GmbH Medizintechnologie
Obstetrics & Gynecology · 81d
Cleared Aug 24, 2006
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
K062169
Applied Medical Resources Corp.
Obstetrics & Gynecology · 24d
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 Mar 04, 2005
MILTEX LAPAROSCOPIC INSTRUMENTS
K043013
Miltex, Inc.
Obstetrics & Gynecology · 122d
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 May 16, 2001
BALLOON CANNULA, SHORT, MODEL R65-985
K010510
A & A Medical, Inc.
Obstetrics & Gynecology · 84d
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 Mar 17, 2000
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
K992481
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Obstetrics & Gynecology · 235d
Cleared Mar 17, 2000
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
K992513
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Obstetrics & Gynecology · 235d
Cleared Feb 07, 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801
Ethicon, Inc.
Obstetrics & Gynecology · 90d
Cleared Oct 14, 1999
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
K990372
Dr. Fritz GmbH
Obstetrics & Gynecology · 248d
Cleared Sep 23, 1999
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
K992480
Medifix, Inc.
Obstetrics & Gynecology · 59d
Cleared Jul 23, 1999
LAP-WAVE 3000 (P07)
K990732
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 140d
Cleared Apr 02, 1999
DCI ENDOSCOPE
K990004
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 18, 1999
BAHO AUTOCLAVABLE LAPAROSCOPE
K982276
Microptix Int'L, LLC
Obstetrics & Gynecology · 234d
Cleared Jan 19, 1999
POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
K982515
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Obstetrics & Gynecology · 183d
Cleared Jan 14, 1999
AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
K982518
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Obstetrics & Gynecology · 178d