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

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K062140 ↗

FDA Product Code

OCL

Models / Variants

Surgifrost Xl Cryosurgical Device, Model 60SFXL

Cryosurgical Console, Model 65CS1

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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

  Class II

  FDA 510(k) K053436 Active Cleared 13 Jan 2006

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  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

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  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