510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854334Substantially Equivalent

Painblocker Wa5000

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

K854334 is the FDA 510(k) clearance record for PAINBLOCKER WA5000, a class II device, cleared for Wallach Surgical Devices, Inc. on under FDA product code GXH (Device, Surgical, Cryogenic). FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K854334.

Clearance record

Decision date
Received
(184 days to decision)
Product code
GXH Device, Surgical, Cryogenic
Regulation
21 CFR 882.4250
Device class
Class II
Review panel
Neurology
Applicant
Wallach Surgical Devices, Inc. 291 Pepe'S Farm Rd., Milford CT
Third party review
No

Clearances, product code GXH

Trailing 12 months

FDA records hold no clearances under product code GXH in the trailing twelve months.

FDA records show no clearances under product code GXH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260