Bipolar Micro Coagulator Models 25-1000 & 25-1200

• • Terminated Z-0527-2015 FDA Class II ·initiated 11 Nov 2014

  The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

510(k) Number

K880863 ↗

FDA Product Code

GEI

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 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

• Electrosurgical Electrode

  Class II

  FDA 510(k) K895331 Active Cleared 15 Sep 1989

See all devices from New England Surgical Instrument Corp. →