HGI · Class II · 21 CFR 884.4120

FDA Product Code HGI: Electrocautery, Gynecologic (and Accessories)

Leading manufacturers include Wallach Surgical Devices, Inc., Utah Medical Products, Inc. and Valleylab, Inc..

53
Total
53
Cleared
297d
Avg days
1977
Since
53 devices
25–48 of 53
Cleared Jul 25, 1995
SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
K944450
Unimed Surgical Products, Inc.
Obstetrics & Gynecology · 316d
Cleared May 04, 1995
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
K921791
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 1115d
Cleared Mar 21, 1995
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
K942986
Aaron Medical Industries
Obstetrics & Gynecology · 293d
Cleared Dec 30, 1994
ELECTROSURGICAL LOOP ELECTRODE
K940191
National Wire & Stamping, Inc.
Obstetrics & Gynecology · 351d
Cleared Dec 12, 1994
FINESSE IEC/601
K941251
Utah Medical Products, Inc.
Obstetrics & Gynecology · 272d
Cleared Sep 27, 1994
SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE
K925333
Aspen Labs
Obstetrics & Gynecology · 706d
Cleared Aug 30, 1994
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
K925560
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 665d
Cleared Jul 20, 1994
WALLACH LEEP PROCEDURE KIT
K935634
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 239d
Cleared Jun 27, 1994
ELECTROSURGICAL ELECTRODE
K925478
Megadyne Medical Products, Inc.
Obstetrics & Gynecology · 606d
Cleared Jun 01, 1994
MODEL 26-0375, ELECTROSURGICAL GENERATOR
K931541
Cameron-Miller, Inc.
Obstetrics & Gynecology · 429d
Cleared May 27, 1994
MODEL 80-1983, ELECTROSURGICAL GENERATOR
K931437
Cameron-Miller, Inc.
Obstetrics & Gynecology · 431d
Cleared May 04, 1994
LEEP AND LLETZ ELECTRODES
K930132
Nordex Medical Corp.
Obstetrics & Gynecology · 477d
Cleared Mar 25, 1994
SEDLACEK HANDLE
K926179
Simpson/Basye, Inc.
Obstetrics & Gynecology · 472d
Cleared Feb 28, 1994
CRYOMEDICS LLETZ LOOPS
K923570
Cabot Medical Corp.
Obstetrics & Gynecology · 591d
Cleared Feb 22, 1994
CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE
K923628
Bruce Mclucas
Obstetrics & Gynecology · 581d
Cleared Feb 16, 1994
16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
K931338
Aaron Medical Industries
Obstetrics & Gynecology · 337d
Cleared Oct 08, 1993
SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
K921386
Silver Creek Surgical
Obstetrics & Gynecology · 564d
Cleared Sep 07, 1993
SURGISTAT
K922206
Valleylab, Inc.
Obstetrics & Gynecology · 483d
Cleared Dec 15, 1992
FORCE 2
K921884
Valleylab, Inc.
Obstetrics & Gynecology · 238d
Cleared Sep 23, 1992
FORCE 1C
K921222
Valleylab, Inc.
Obstetrics & Gynecology · 194d
Cleared Apr 28, 1992
ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
K914367
Gyne-Tech Instrument Corp.
Obstetrics & Gynecology · 210d
Cleared Apr 02, 1992
SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
K914329
Ellman Intl. Mfg., Inc.
Obstetrics & Gynecology · 188d
Cleared Mar 05, 1992
SINGLE USE LEE ELECTRODE
K912046
Aspen Labs
Obstetrics & Gynecology · 302d
Cleared Feb 13, 1992
SINGLE USE LEE ELECTRODE
K913213
Aspen Laboratories, Inc.
Obstetrics & Gynecology · 209d