Product Code: JOS FDA class 2 21 CFR 878.4400

Electrode, Electrosurgical

General, Plastic Surgery

The Electrode, Electrosurgical is a surgical device used in electrosurgical procedures to deliver radiofrequency electrical current to tissue for cutting, coagulation, or ablation during general and plastic surgery operations, functioning as the active component through which current passes to the patient. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOS and is regulated under 21 CFR 878.4400, within the General, Plastic Surgery medical specialty. This device 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: JOS
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 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K161600	Resection Electrodes	Sep 06, 2016	Substantially Equivalent	Olympus Winter & Ibe GmbH
K050923	LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR	May 18, 2005	Substantially Equivalent	Conmed Linvatec
K012684	REPROCESSED ELECTROSURGICAL ELECTRODE	Jan 18, 2002	Substantially Equivalent	Sterilmed, Inc.
K011515	MEDLINE GROUNDING PAD	Jul 13, 2001	Substantially Equivalent	Medline Industries, Inc.
K003403	ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999	May 07, 2001	Substantially Equivalent	Highland / Marietta, Inc.
K000333	STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD	May 03, 2000	Substantially Equivalent	Triad Surgical Technologies, Inc.
K993885	ULTRABLATOR ELECTRODE	Feb 10, 2000	Substantially Equivalent	Linvatec Corp.
K991830	CAPSULAR SHRINKAGE ELECTRODE	Aug 20, 1999	Substantially Equivalent	Linvatec Corp.
K974735	STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE	Jun 24, 1998	Substantially Equivalent	Aaron Medical Industries
K973554	VALLEY FORGE BIPOLAR BALL TIP ELECTRODE	Dec 19, 1997	Substantially Equivalent	Valley Forge Scientific Corp.
K971187	STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE	May 05, 1997	Substantially Equivalent	Aaron Medical Industries
K962544	MICRO DIAMOND-POINT DISSECTION NEEDLES	Sep 20, 1996	Substantially Equivalent	Dsp Worldwide
K962313	MODIFIED LEVEEN NEEDLE ELECTRODE	Sep 11, 1996	Substantially Equivalent	Radiotherapeutics Corp.
K955636	SENTRY DISPOSABLE DISPERSIVE ELECTRODE	Mar 27, 1996	Substantially Equivalent	Sentry Medical Products, Inc.
K952323	MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES	Jun 23, 1995	Substantially Equivalent	Mist, Inc.
K952290	MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES	Jun 23, 1995	Substantially Equivalent	Mist, Inc.
K950455	DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES	May 16, 1995	Substantially Equivalent	Aaron Medical Industries
K944992	ELECTRODES	Apr 27, 1995	Substantially Equivalent	Linvatec Corp.
K923037	MILES SODIUM METHOD	Sep 22, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K905060	ELECTRODE EXTENDER	Apr 12, 1991	Substantially Equivalent	Megadyne Medical Products, Inc.
K903302	ELECTRODE, ELECTROSURGERY	Oct 02, 1990	Substantially Equivalent	Megadyne Medical Products, Inc.
K895331	ELECTROSURGICAL ELECTRODE	Sep 15, 1989	Substantially Equivalent	New England Surgical Instrument Corp.
K891400	MICRO CAUTERY NEEDLES	Apr 06, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K890973	STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE	Mar 22, 1989	Substantially Equivalent	Instrument Makar, Inc.
K890972	HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE	Mar 22, 1989	Substantially Equivalent	Instrument Makar, Inc.
K882421	INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE	Jun 30, 1988	Substantially Equivalent	Dermacare Products, Inc.
K881763	COLORADO NEEDLE ELECTRODE	Jun 20, 1988	Substantially Equivalent	Colorado Biomedical, Inc.
K881144	YESNG PATIENT PLATE #80226	Apr 08, 1988	Substantially Equivalent	Ferguson Medical
K874719	STRATUM ESU	Feb 16, 1988	Substantially Equivalent	Alternative Design Systems, Inc.
K873655	MONOPOLAR CAUTERY RETROGADE TIP #TM-1703	Dec 15, 1987	Substantially Equivalent	Arthropedics, Inc.
K873654	MONOPOLAR CAUTERY CONICAL TIP #TM-1702	Dec 15, 1987	Substantially Equivalent	Arthropedics, Inc.
K873653	MONOPOLAR CAUTERY BLADE TIP #TM-1701	Dec 15, 1987	Substantially Equivalent	Arthropedics, Inc.
K810628	ELECTROSURGICAL CUTTING & COAGULATION	Apr 03, 1981	Substantially Equivalent	Intermedics, Inc.
K792365	BIPOLAR FORCEPS	Dec 10, 1979	Substantially Equivalent	Concept, Inc.
K780405	INFANT ELECTROSURGICAL GROUNDING PAD	Apr 05, 1978	Substantially Equivalent	New Dimensions IN Medicine, Inc.
K772160	ELECTROSURGICAL GROUNDING PAD	Nov 28, 1977	Substantially Equivalent	Ndm Corp.