Wallach Cardiac Cryosurgical System 800

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Wccs 800 Wallach Cardiac Cryosurgical System

510(k) Number

K880416 ↗

FDA Product Code

GEH

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K984306 Active Cleared 1 Mar 1999

• Wallach Cc/Brush

  Class II

  FDA 510(k) K896065 Active Cleared 4 Jan 1990

• Photostar V-8

  Class II

  FDA 510(k) K871681 Active Cleared 5 Aug 1987

• Wallach Ultra Freeze

  Class II

  FDA 510(k) K935010 Active Cleared 9 Feb 1994

• Clean Air

  Class II

  FDA 510(k) K943201 Active Cleared 28 Feb 1995

• Wallach Leap 100 Electro Surgery System

  Class II

  FDA 510(k) K921791 Active Cleared 4 May 1995

See all devices from Wallach Surgical Devices, Inc. →

• What is the Wallach Cardiac Cryosurgical System 800 used for?

  The Wallach Cardiac Cryosurgical System 800 is a cryosurgical device that uses controlled extreme cold to destroy targeted tissue without cutting or thermal burns. It is primarily employed in cardiac and general surgical procedures where precise tissue ablation is required, such as in arrhythmia treatments or tumor removals.

• Is the Wallach Cardiac Cryosurgical System 800 reusable or single-use?

  The Wallach Cardiac Cryosurgical System 800 is designed as a reusable medical device. It must be maintained and sterilized according to standard surgical instrument protocols to ensure functionality and sterility for repeated use in sterile surgical environments.

• What accessories or probes are included with the Wallach Cardiac Cryosurgical System 800?

  The system includes multiple accessories and probes, as indicated by the associated FDA product codes (e.g., 3002987034, 3010242262, etc.). These accessories are intended to complement the device’s cryosurgical capabilities, enabling precise tissue ablation in various surgical applications.

• How should the Wallach Cardiac Cryosurgical System 800 be stored?

  The device must be stored and handled in compliance with standard surgical instrument protocols to maintain sterility and functionality. Since it is reusable, proper cleaning, sterilization, and storage procedures are critical to prevent contamination and ensure safe, repeated use in clinical settings.

• What regulatory pathway was followed for the Wallach Cardiac Cryosurgical System 800?

  The Wallach Cardiac Cryosurgical System 800 received FDA 510(k) clearance (K880416) under the General, Plastic Surgery advisory committee. The clearance was granted through a traditional pathway, confirming its substantial equivalence to a predicate device under FDA regulation 878.4350.