Sanarus Visica Treatment System

• • Terminated Z-1008-03 FDA Unclassified (pre-2012) ·initiated 16 Jun 2003 ·on shared 510(k) K022314

  Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

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

510(k) Number

K022314 ↗

FDA Product Code

GEH

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Modification to:sanarus Visica Treatment System, Models VS2000

  Class II

  FDA 510(k) K052861 Active Cleared 15 Nov 2005

• V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600

  Class II

  FDA 510(k) K062896 Active Cleared 3 Jan 2007

• Sanarus Centrica Core Tissue Biopsy System

  Class II

  FDA 510(k) K021137 Active Cleared 26 Jun 2002

• Sanarus Centrica II Rotational Core Biopsy System

  Class II

  FDA 510(k) K032506 Active Cleared 9 Oct 2003

• Modification to Sanarus Centrica Core Tissue Biopsy

  Class II

  FDA 510(k) K022879 Active Cleared 23 Sep 2002

• Modification to Sanarus Visica Treatment System

  Class II

  FDA 510(k) K021211 Active Cleared 26 Jun 2002

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