Surgifrost 6cm, 7cm and 10 Cm Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console

• • Terminated Z-0079-2007 FDA Unclassified (pre-2012) ·initiated 5 May 2006 ·on shared 510(k) K053436

  Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K053436 ↗

FDA Product Code

OCL

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Surgifrost Xl Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1

  Class II

  FDA 510(k) K062140 Active Cleared 24 Aug 2006

• Surgifrost 10 Cm Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console

  Class II

  FDA 510(k) K040690 Active Cleared 29 Apr 2004

• Freezor Xtra Surgical Cardiac Cryoablation Device and CCT.2 Cardiac Cardiac Cryoablation Cryoconsole

  Class II

  FDA 510(k) K030303 Active Cleared 29 Apr 2003

• Flexcath Steerable Sheath & Dilator

  Class II

  FDA 510(k) K070357 Active Cleared 28 Dec 2007

• Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12

  Class II

  FDA 510(k) K081049 Active Cleared 27 Jun 2008