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
73–96 of 338
Cleared Aug 10, 1995
STRYKER OPERATING LAPAROSCOPE
K943100
Stryker Endoscopy
Obstetrics & Gynecology · 407d
Cleared Jul 20, 1995
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
K951394
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 114d
Cleared Jul 12, 1995
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K950962
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 132d
Cleared Jun 14, 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951190
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared May 25, 1995
KSE STEINER ELECTROMECHANIC MORCELLATOR
K946147
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 160d
Cleared May 11, 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K946359
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 132d
Cleared May 05, 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 165d
Cleared Apr 25, 1995
AESCULAP LAPAROSCOPES
K942730
Aesculap, Inc.
Obstetrics & Gynecology · 320d
Cleared Mar 30, 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
K945211
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 156d
Cleared Mar 29, 1995
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
K943603
Aesculap, Inc.
Obstetrics & Gynecology · 247d
Cleared Mar 21, 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K945982
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 103d
Cleared Mar 16, 1995
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
K950232
Olympus America, Inc.
Obstetrics & Gynecology · 66d
Cleared Feb 28, 1995
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
K932276
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 657d
Cleared Feb 28, 1995
TROCAR AND CANNULA ACCESSORY
K945741
Applied Medical Resources
Obstetrics & Gynecology · 97d
Cleared Feb 13, 1995
CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE
K946235
Conmedcorp
Obstetrics & Gynecology · 53d
Cleared Jan 24, 1995
KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE
K945100
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 98d
Cleared Jan 06, 1995
STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360
K936273
Baxter Healthcare Corp
Obstetrics & Gynecology · 388d
Cleared Dec 30, 1994
ENDOSCOPE
K944555
United States Surgical, A Division of Tyco Healthc
Obstetrics & Gynecology · 105d
Cleared Dec 21, 1994
CONMED TROGARD
K934799
Conmedcorp
Obstetrics & Gynecology · 440d
Cleared Dec 15, 1994
HASSON OPEN LAPAROSCOPY CANNULA
K942447
Linvatec Corp.
Obstetrics & Gynecology · 206d
Cleared Nov 30, 1994
LAPAROVIEW
K931065
Northgate Technologies, Inc.
Obstetrics & Gynecology · 639d
Cleared Nov 17, 1994
INSUFFLATOR TUBING WITH FILTER
K943508
Stryker Endoscopy
Obstetrics & Gynecology · 120d
Cleared Sep 28, 1994
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478
Carl Zeiss, Inc.
Obstetrics & Gynecology · 553d
Cleared Jun 21, 1994
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
K940505
Uresil Corp.
Obstetrics & Gynecology · 138d