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
121–144 of 338
Cleared Sep 15, 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200
Olympus America, Inc.
Obstetrics & Gynecology · 382d
Cleared Sep 07, 1995
KARL STORZ SUCTION CATHETERS
K951250
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 171d
Cleared Aug 25, 1995
FLOW-THERME, WISAP #7642
K952508
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Obstetrics & Gynecology · 86d
Cleared Aug 10, 1995
STRYKER OPERATING LAPAROSCOPE
K943100
Stryker Endoscopy
Obstetrics & Gynecology · 407d
Cleared Jul 25, 1995
DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE
K941206
New Eder Corp.
Obstetrics & Gynecology · 498d
Cleared Jul 25, 1995
CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS
K944270
Chirurgische Instrumente
Obstetrics & Gynecology · 327d
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 Jul 06, 1995
NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
K946380
American Hydro-Surgical Instruments, Inc.
Obstetrics & Gynecology · 205d
Cleared Jun 30, 1995
TORCARS,CANNULAE,SHEATHS,OBTURATORS
K943713
Karl Storz Endoskop GmbH
Obstetrics & Gynecology · 333d
Cleared Jun 14, 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951190
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 13, 1995
LASEVAC
K951490
D.D. Surgical, Inc.
Obstetrics & Gynecology · 74d
Cleared May 25, 1995
LAPARASCOPE
K943662
Pollux Endoscopy, Inc.
Obstetrics & Gynecology · 301d
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 11, 1995
R-MED MINI-RETRACTOR
K950108
R-Med, Inc.
Obstetrics & Gynecology · 120d
Cleared May 05, 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 165d
Cleared May 05, 1995
CANNUAL AND TROCAR, SUPERPUBIC
K950457
Core Dynamics, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 25, 1995
AESCULAP LAPAROSCOPES
K942730
Aesculap, Inc.
Obstetrics & Gynecology · 320d
Cleared Mar 31, 1995
R-MED DISPOSABLE PLUG
K942411
R-Med, Inc.
Obstetrics & Gynecology · 315d
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
BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.
K932779
Birtcher Medical Systems, Inc.
Obstetrics & Gynecology · 651d
Cleared Mar 21, 1995
KSEA SEMM TISSUR PUNCH
K943053
Karl Storz Endoskop GmbH
Obstetrics & Gynecology · 267d