Vivawave Microwave Ablation System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K053535 ↗

FDA Product Code

NEY

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Models E2502B/E2525 Reusable Handswitching Pencils

  Class II

  FDA 510(k) K914400 Active Cleared 17 Oct 1991

• Cusa System 200C, T & M Ultrasonic Surgical Aspira.

  Unclassified

  FDA 510(k) K884412 Active Cleared 2 Dec 1988

• Valleylab Procision(Tm) System

  Class II

  FDA 510(k) K945688 Active Cleared 13 Jun 1995

• Ligasure 5mm Blunt Tip Laparoscopic Sealer-Divider

  Class II

  FDA 510(k) K092879 Active Cleared 16 Oct 2009

• Davis Bayonet Electrodes

  Class II

  FDA 510(k) K964602 Active Cleared 9 Jan 1997

• Force Gsu System Model No. Gsu-20 and Gsu-22

  Class II

  FDA 510(k) K942579 Active Cleared 21 Sep 1994

See all devices from Valleylab, Inc. →