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
49–72 of 338
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
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 Jul 22, 1997
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
K971797
Louisville Laboratories, Inc.
Obstetrics & Gynecology · 68d
Cleared May 05, 1997
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
K965045
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 139d
Cleared Apr 21, 1997
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
K971255
Imagyn Medical, Inc.
Obstetrics & Gynecology · 17d
Cleared Apr 04, 1997
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
K963076
Louisville Laboratories, Inc.
Obstetrics & Gynecology · 240d
Cleared Mar 20, 1997
CANNULA
K965121
Origin Medsystems, Inc.
Obstetrics & Gynecology · 87d
Cleared Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151
Smith & Nephew, Inc.
Obstetrics & Gynecology · 62d
Cleared Mar 06, 1997
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
K965055
Imagyn Medical, Inc.
Obstetrics & Gynecology · 78d