Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode

• • Terminated Z-1347-2013 FDA Class II ·initiated 15 Feb 2013

  Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.

510(k) Number

K970066 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Surgi-Link Endoscopic Bipolar Forceps

  Class II

  FDA 510(k) K944045 Active Cleared 8 Sep 1994

• Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode

  Class II

  FDA 510(k) K962935 Active Cleared 3 Sep 1996

• Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and Tip Cleaner, Unimed Disposable Hand and F

  Class II

  FDA 510(k) K993647 Active Cleared 16 Nov 1999

• Needle Elctrode

  Class II

  FDA 510(k) K944265 Active Cleared 5 May 1995

• Surgi-Link Bipolar Micro Forceps

  Class II

  FDA 510(k) K946246 Active Cleared 7 Mar 1995

• Surgi-Link Electrosurgical Electrode

  Class II

  FDA 510(k) K944433 Active Cleared 26 Sep 1994

See all devices from Unimed Surgical Products, Inc. →