HGI · Class II · 21 CFR 884.4120

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

Leading manufacturers include Utah Medical Products, Inc., Valleylab, Inc. and Aaron Medical Industries.

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 Jul 03, 1997
TBD
K965245
Utah Medical Products, Inc.
Obstetrics & Gynecology · 184d
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 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
Cleared Mar 21, 1995
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
K942986
Aaron Medical Industries
Obstetrics & Gynecology · 293d
Cleared Dec 12, 1994
FINESSE IEC/601
K941251
Utah Medical Products, Inc.
Obstetrics & Gynecology · 272d
Cleared Aug 30, 1994
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
K925560
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 665d
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

About Product Code HGI - Regulatory Context