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
49–53 of 53
Cleared Sep 18, 1991
UTAH ESSU
K905263
Utah Medical Products, Inc.
Obstetrics & Gynecology · 299d
Cleared Sep 17, 1991
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
K905747
Coopervision Surgical
Obstetrics & Gynecology · 267d
Cleared Apr 26, 1990
ENDOCOAGULATOR 2001 KLI
K895402
Cabot Medical Corp.
Obstetrics & Gynecology · 231d
Cleared Mar 09, 1977
MONITOR, FETAL HEART, MODEL 1980
K770292
Berkeley Bio-Engineering
Obstetrics & Gynecology · 23d
Cleared Mar 09, 1977
ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
K770295
Brattle Instrument Corp.
Obstetrics & Gynecology · 23d