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 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 Feb 28, 1994
CRYOMEDICS LLETZ LOOPS
K923570
Cabot Medical Corp.
Obstetrics & Gynecology · 591d
Cleared Feb 16, 1994
16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
K931338
Aaron Medical Industries
Obstetrics & Gynecology · 337d
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 Feb 13, 1992
SINGLE USE LEE ELECTRODE
K913213
Aspen Laboratories, Inc.
Obstetrics & Gynecology · 209d
Cleared Sep 18, 1991
UTAH ESSU
K905263
Utah Medical Products, Inc.
Obstetrics & Gynecology · 299d
Cleared Apr 26, 1990
ENDOCOAGULATOR 2001 KLI
K895402
Cabot Medical Corp.
Obstetrics & Gynecology · 231d