Product Code: HAM FDA class 2 21 CFR 878.4400

Apparatus, Electrosurgical

General, Plastic Surgery

The Electrosurgical Apparatus is a surgical device that uses high-frequency electrical current to cut tissue and coagulate blood vessels to control bleeding during surgical procedures across a wide range of specialties, including general and plastic surgery. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HAM under regulation 21 CFR 878.4400 in the General, Plastic Surgery 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: HAM
Device Class: FDA class 2
Regulation Number: 878.4400
Medical Specialty: General, Plastic Surgery
Review Panel: SU
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 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K153472	Quiver Laparoscopic Extendable	Jun 23, 2016	Substantially Equivalent	Itl Corporation Pty, Ltd.
K000079	NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M	Feb 04, 2000	Substantially Equivalent	Nikomed U.S.A., Inc.
K993306	NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)	Nov 03, 1999	Substantially Equivalent	Paladin Medical, Inc.
K945861	BERGEN 710 ESU	Mar 01, 1995	Substantially Equivalent	Bergen Mfg.
K913300	LAPAROSTAT(TM)	Apr 02, 1992	Substantially Equivalent	Cook Ob/Gyn
K920100	GSU HANDPIECE ADAPTER	Feb 03, 1992	Substantially Equivalent	Beacon Laboratories, Inc.
K911353	EMC MODEL NO. STATOME 900	Jun 24, 1991	Substantially Equivalent	Emc Industries
K901248	ABC HANDPIECE ADAPTER	Apr 03, 1990	Substantially Equivalent	Beacon Laboratories, Inc.
K881334	LIGHT COAGULATOR LC 250	Nov 16, 1989	Substantially Equivalent	Nk-Optik GmbH
K895337	ELECTROSURGICAL COAGULATION SUCTION TUBE	Sep 15, 1989	Substantially Equivalent	New England Surgical Instrument Corp.
K894762	B100 DISPOSABLE HANDPIECE	Sep 15, 1989	Substantially Equivalent	Beacon Laboratories, Inc.
K894663	BEAMER ONE	Sep 15, 1989	Substantially Equivalent	Beacon Laboratories, Inc.
K884175	#820/821 BIPOLAR FORCEPS	Oct 24, 1988	Substantially Equivalent	Olsen Electrosurgical, Inc.
K884174	MODIFIED OLSEN 755/756 SWITCHPENS	Oct 24, 1988	Substantially Equivalent	Olsen Electrosurgical, Inc.
K884173	#920 DISPOSABLE TUR CABLE	Oct 24, 1988	Substantially Equivalent	Olsen Electrosurgical, Inc.
K884172	MODIFIED OLSEN #770 DISPOSABLE HOLSTER	Oct 24, 1988	Substantially Equivalent	Olsen Electrosurgical, Inc.
K884171	#875 DISPOSABLE BIOPOLAR CABLE	Oct 24, 1988	Substantially Equivalent	Olsen Electrosurgical, Inc.
K871435	BARD EMS SYSTEM 6000 E.S.U.	May 11, 1987	Substantially Equivalent	C.R. Bard, Inc.
K863091	BICORD BY QMED	Aug 29, 1986	Substantially Equivalent	Qmed, Inc.
K853291	GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300	Oct 10, 1985	Substantially Equivalent	Bio-Detek, Inc.
K852184	ELECTRO-CAUTERY KNIFE CLEANER 6000 1	Jun 04, 1985	Substantially Equivalent	Dlp, Inc.
K833648	OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S	Nov 29, 1983	Substantially Equivalent	Edward Weck, Inc.
K823755	BICEPS ELECTROCAUTERY SYSTEM	Jan 26, 1983	Substantially Equivalent	Squibb Diagnostics
K820664	DISPOSABLE ELECTRODE	Mar 19, 1982	Substantially Equivalent	Trident Surgical Corp.
K810920	NDM DIATEMP INFANT ELECTROSURG. DISP. P.	May 01, 1981	Substantially Equivalent	Ndm Corp.
K810909	MICRO CAUTERY	Apr 17, 1981	Substantially Equivalent	Key Medical, Inc.
K810015	MULTIHI-TEMP CAUTERY	Feb 12, 1981	Substantially Equivalent	Medical Products Development, Inc.
K810014	REPLACABLE BATTERY HI-TEMP CAUTERY	Feb 12, 1981	Substantially Equivalent	Medical Products Development, Inc.
K780293	ELECTROSURGICAL UNIT	Mar 14, 1978	Substantially Equivalent	Ritter Co.
K780118	ELECTRODE, DISPERSIVE, DISP. NEOPAD	Feb 23, 1978	Substantially Equivalent	Neomed Corp.
K771186	MICRO BI-POLAR FORCEPS #39-200	Jul 15, 1977	Substantially Equivalent	Edward Weck, Inc.