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
49–72 of 338
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
Cleared Oct 09, 1998
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
K982428
Innervision, 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 21, 1998
LAPARO-TENSER
K970712
L & T S.N.C. DI E. Lucini & C.
Obstetrics & Gynecology · 510d
Cleared Jul 10, 1998
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K974763
Deroyal Industries, Inc.
Obstetrics & Gynecology · 203d
Cleared May 21, 1998
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
K970968
Guenter Bissinger Medizintechnik GmbH
Obstetrics & Gynecology · 430d
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 Apr 01, 1998
LIGHTSOURCE OR ILLUMINATOR
K980166
Cuda Products Co.
Obstetrics & Gynecology · 75d
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 Oct 10, 1997
GALILEO HIGH RESOLUTION MICRO COUPLER
K971896
Netoptix Corp.
Obstetrics & Gynecology · 141d