Radionics Single Use Ground Pad (Dgp-Hp)

• • Terminated Z-2301-2012 FDA Class II ·initiated 1 Aug 2012

  Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.

510(k) Number

K030697 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Radionics Disposable Rf Cannulae (Sc-C, Rfk-Db, Rfk-Ds)

  Class II

  FDA 510(k) K980430 Active Cleared 16 Mar 1998

• Rfg-3CF

  Class II

  FDA 510(k) K965182 Active Cleared 12 Mar 1997

• Radionics Microelectrode Kit

  Class II

  FDA 510(k) K991399 Active Cleared 21 Sep 1999

• Radionics Xdc External Ventricular Catheter

  Class II

  FDA 510(k) K992379 Active Cleared 8 Sep 1999

• Ocular-Biometer 4000

  Class II

  FDA 510(k) K820042 Active Cleared 22 Jul 1982

• Pace-1A Cardiac Stimulator

  Class II

  FDA 510(k) K963579 Active Cleared 8 Nov 1996

See all devices from Radionics, Inc. →