Product Code: HGI FDA class 2 21 CFR 884.4120

Electrocautery, Gynecologic (And Accessories)

Obstetrics/Gynecology

The Gynecologic Electrocautery (and accessories) is a device that uses an electrically heated element to cauterize, coagulate, or destroy tissue in the female reproductive tract, used for procedures such as treatment of cervical erosion or minor lesions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGI, regulated under 21 CFR 884.4120, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HGI
Device Class: FDA class 2
Regulation Number: 884.4120
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K202915	IRIS Thermocoagulator and Digital Colposcope	Apr 23, 2021	Substantially Equivalent	Liger Medical, LLC
K152843	Liger Medical HTU-110	Jun 24, 2016	Substantially Equivalent	Liger Medical, LLC
K130606	FMWAND FERROMAGNETIC SURGICAL SYSTEM	Jan 03, 2014	Substantially Equivalent	Domain Surgical, Inc.
K121881	DOMAIN SURGICAL SYSTEM	Oct 18, 2012	Substantially Equivalent	Domain Surgical, Inc.
K070877	ENDOCERVICAL ELECTRODE # 2	Jul 27, 2007	Substantially Equivalent	Modern Medical Equipment Mfg., Ltd.
K061651	FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158	Oct 20, 2006	Substantially Equivalent	Apple Medical Corp.
K022593	THOMAS MEDICAL ELECTRODES	Nov 01, 2002	Substantially Equivalent	Thomas Medical, Inc.
K003608	SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY	Feb 20, 2001	Substantially Equivalent	Aesculap, Inc.
K002042	TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018	Feb 01, 2001	Substantially Equivalent	New England Medical Corp.
K993527	LOOP ELECTRODE, BALL ELECTRODE	Jul 06, 2000	Substantially Equivalent	Palm Medical USA, Inc.
K993777	DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES	May 25, 2000	Substantially Equivalent	R-Group Intl.
K983840	WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)	May 20, 1999	Substantially Equivalent	Wallach Surgical Devices, Inc.
K982739	GYNEX ELECTRODES	Mar 12, 1999	Substantially Equivalent	Gynex Corp.
K974138	ROCKET ELECTRODE	Jan 30, 1998	Substantially Equivalent	A & A Medical, Inc.
K971986	VALLEY FORGE BIPOLAR LOOP	Aug 26, 1997	Substantially Equivalent	Valley Forge Scientific Corp.
K965245	TBD	Jul 03, 1997	Substantially Equivalent	Utah Medical Products, Inc.
K963653	WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM	Jun 11, 1997	Substantially Equivalent	Wallach Surgical Devices, Inc.
K963348	WALLACH INTEGRATION UNIT	Mar 19, 1997	Substantially Equivalent	Wallach Surgical Devices, Inc.
K963852	KSEA THERMOCOAGULATOR (MODEL 265100 20)	Dec 10, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K955756	KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR	Nov 26, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K961460	LWEET CONE BIOPSY INSTRUMENT	Nov 19, 1996	Substantially Equivalent	Apple Medical Corp.
K952030	LOOP/SQUARE ELECTRODE	Jul 31, 1996	Substantially Equivalent	E & M Engineering, Inc.
K955093	ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511	Apr 29, 1996	Substantially Equivalent	Utah Medical Products, Inc.
K952483	LEEP SYSTEM 1000	Oct 06, 1995	Substantially Equivalent	CooperSurgical, Inc.
K944450	SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE	Jul 25, 1995	Substantially Equivalent	Unimed Surgical Products, Inc.
K921791	WALLACH LEAP 100 ELECTRO SURGERY SYSTEM	May 04, 1995	Substantially Equivalent	Wallach Surgical Devices, Inc.
K942986	ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)	Mar 21, 1995	Substantially Equivalent	Aaron Medical Industries
K940191	ELECTROSURGICAL LOOP ELECTRODE	Dec 30, 1994	Substantially Equivalent	National Wire & Stamping, Inc.
K941251	FINESSE IEC/601	Dec 12, 1994	Substantially Equivalent	Utah Medical Products, Inc.
K925333	SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE	Sep 27, 1994	Substantially Equivalent	Aspen Labs
K925560	ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES	Aug 30, 1994	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K935634	WALLACH LEEP PROCEDURE KIT	Jul 20, 1994	Substantially Equivalent	Wallach Surgical Devices, Inc.
K925478	ELECTROSURGICAL ELECTRODE	Jun 27, 1994	Substantially Equivalent	Megadyne Medical Products, Inc.
K931541	MODEL 26-0375, ELECTROSURGICAL GENERATOR	Jun 01, 1994	Substantially Equivalent	Cameron-Miller, Inc.
K931437	MODEL 80-1983, ELECTROSURGICAL GENERATOR	May 27, 1994	Substantially Equivalent	Cameron-Miller, Inc.
K930132	LEEP AND LLETZ ELECTRODES	May 04, 1994	Substantially Equivalent	Nordex Medical Corp.
K926179	SEDLACEK HANDLE	Mar 25, 1994	Substantially Equivalent	Simpson/Basye, Inc.
K923570	CRYOMEDICS LLETZ LOOPS	Feb 28, 1994	Substantially Equivalent	Cabot Medical Corp.
K923628	CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE	Feb 22, 1994	Substantially Equivalent	Bruce Mclucas
K931338	16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)	Feb 16, 1994	Substantially Equivalent	Aaron Medical Industries
K921386	SUOP ELECTRODES FOR EXCISIONAL PROCEDURES	Oct 08, 1993	Substantially Equivalent	Silver Creek Surgical
K922206	SURGISTAT	Sep 07, 1993	Substantially Equivalent	Valleylab, Inc.
K921884	FORCE 2	Dec 15, 1992	Substantially Equivalent	Valleylab, Inc.
K921222	FORCE 1C	Sep 23, 1992	Substantially Equivalent	Valleylab, Inc.
K914367	ELECTROSURGICAL GENERATOR MODEL ESU100/250/550	Apr 28, 1992	Substantially Equivalent	Gyne-Tech Instrument Corp.
K914329	SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION	Apr 02, 1992	Substantially Equivalent	Ellman Intl. Mfg., Inc.
K912046	SINGLE USE LEE ELECTRODE	Mar 05, 1992	Substantially Equivalent	Aspen Labs
K913213	SINGLE USE LEE ELECTRODE	Feb 13, 1992	Substantially Equivalent	Aspen Laboratories, Inc.
K905263	UTAH ESSU	Sep 18, 1991	Substantially Equivalent	Utah Medical Products, Inc.
K905747	LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR	Sep 17, 1991	Substantially Equivalent	Coopervision Surgical
K895402	ENDOCOAGULATOR 2001 KLI	Apr 26, 1990	Substantially Equivalent	Cabot Medical Corp.
K770295	ABDOMINAL ECG PROCESSOR FOR FETAL MONI.	Mar 09, 1977	Substantially Equivalent	Brattle Instrument Corp.
K770292	MONITOR, FETAL HEART, MODEL 1980	Mar 09, 1977	Substantially Equivalent	Berkeley Bio-Engineering