510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K880416Substantially Equivalent

Wccs 800 Wallach Cardiac Cryosurgical System

CooperSurgical, Inc., Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880416 is the FDA 510(k) clearance record for WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM, a class II device, cleared for Wallach Surgical Devices, Inc. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K880416.

Clearance record

Decision date
Received
(238 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Wallach Surgical Devices, Inc. 291 Pepe'S Farm Rd., Milford CT
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260