510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K935010Substantially Equivalent

Wallach Ultra Freeze

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

K935010 is the FDA 510(k) clearance record for WALLACH ULTRA FREEZE, 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 K935010.

Clearance record

Decision date
Received
(112 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
510(k) summary
Statement
Third party review
No

Clearances, product code GEH

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