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

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 Jun 24, 2016
Liger Medical HTU-110
K152843
Liger Medical, LLC
Obstetrics & Gynecology · 269d
Cleared Jan 03, 2014
FMWAND FERROMAGNETIC SURGICAL SYSTEM
K130606
Domain Surgical, Inc.
Obstetrics & Gynecology · 302d
Cleared Oct 18, 2012
DOMAIN SURGICAL SYSTEM
K121881
Domain Surgical, Inc.
Obstetrics & Gynecology · 114d
Cleared Jul 27, 2007
ENDOCERVICAL ELECTRODE # 2
K070877
Modern Medical Equipment Mfg., Ltd.
Obstetrics & Gynecology · 120d
Cleared Oct 20, 2006
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
K061651
Apple Medical Corp.
Obstetrics & Gynecology · 129d
Cleared Nov 01, 2002
THOMAS MEDICAL ELECTRODES
K022593
Thomas Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Feb 20, 2001
SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
K003608
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 01, 2001
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
K002042
New England Medical Corp.
Obstetrics & Gynecology · 211d
Cleared Jul 06, 2000
LOOP ELECTRODE, BALL ELECTRODE
K993527
Palm Medical USA, Inc.
Obstetrics & Gynecology · 262d
Cleared May 25, 2000
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
K993777
R-Group Intl.
Obstetrics & Gynecology · 199d
Cleared May 20, 1999
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
K983840
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 202d
Cleared Mar 12, 1999
GYNEX ELECTRODES
K982739
Gynex Corp.
Obstetrics & Gynecology · 218d
Cleared Jan 30, 1998
ROCKET ELECTRODE
K974138
A & A Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Aug 26, 1997
VALLEY FORGE BIPOLAR LOOP
K971986
Valley Forge Scientific Corp.
Obstetrics & Gynecology · 89d
Cleared Jul 03, 1997
TBD
K965245
Utah Medical Products, Inc.
Obstetrics & Gynecology · 184d
Cleared Jun 11, 1997
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
K963653
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 272d
Cleared Mar 19, 1997
WALLACH INTEGRATION UNIT
K963348
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 205d
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
Cleared Nov 19, 1996
LWEET CONE BIOPSY INSTRUMENT
K961460
Apple Medical Corp.
Obstetrics & Gynecology · 217d
Cleared Jul 31, 1996
LOOP/SQUARE ELECTRODE
K952030
E & M Engineering, Inc.
Obstetrics & Gynecology · 457d
Cleared Apr 29, 1996
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
K955093
Utah Medical Products, Inc.
Obstetrics & Gynecology · 174d
Cleared Oct 06, 1995
LEEP SYSTEM 1000
K952483
CooperSurgical, Inc.
Obstetrics & Gynecology · 129d

About Product Code HGI - Regulatory Context