HGI · Class II · 21 CFR 884.4120

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

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Aesculap, Inc. and Liger Medical, LLC.

53
Total
53
Cleared
297d
Avg days
1977
Since

FDA 510(k) Cleared Electrocautery, Gynecologic (and Accessories) Devices (Product Code HGI)

53 devices
1–24 of 53
Cleared Apr 23, 2021
IRIS Thermocoagulator and Digital Colposcope
K202915
Liger Medical, LLC
Obstetrics & Gynecology · 206d
Cleared Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K003608
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 10, 1996
KSEA THERMOCOAGULATOR (MODEL 265100 20)
K963852
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 76d
Cleared Nov 26, 1996
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
K955756
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 343d

About Product Code HGI - Regulatory Context