Electrosurgical Electrode

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K895331 ↗

FDA Product Code

JOS

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Chisel (Osteotome, Gouge, Etc.)

  Class I

  FDA 510(k) K864775 Active Cleared 12 Feb 1987

• Bipolar Micro Coagulator Models 25-1000 & 25-1200

  Class II

  FDA 510(k) K880863 Active Cleared 19 Apr 1988

• Bipolar Coagulating Forceps

  Class II

  FDA 510(k) K811820 Active Cleared 28 Jul 1981

• Bipolar Card

  Class II

  FDA 510(k) K831236 Active Cleared 2 Jun 1983

• Raney and Leroy-Raney Scalp Clip

  Class II

  FDA 510(k) K883963 Active Cleared 7 Oct 1988

• Cranio Blades and Wire Pass Drill

  Class I

  FDA 510(k) K861876 Active Cleared 30 May 1986

See all devices from New England Surgical Instrument Corp. →

• What is the electrosurgical electrode used for?

  The electrosurgical electrode is used to deliver electrical current for cutting, coagulating, or ablating tissue during surgical procedures, specifically intended for use in general and plastic surgery settings as indicated in its FDA 510(k) clearance.

• Who manufactures the electrosurgical electrode and where are they located?

  The electrosurgical electrode is manufactured by New England Surgical Instrument Corp., located at P.O. Box 35, 83 E. Water St., Rockland, MA 02370, United States, as specified in the device authorization records.

• What regulatory pathway was used for this electrosurgical electrode?

  This device received traditional 510(k) clearance (K895331) from the FDA on September 15, 1989, and is substantially equivalent to a legally marketed predicate device under FDA regulation 878.4400 with product code JOS.