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Compound W®

by Medtech Products, Inc.

Compound W® is a Class II device made by Medtech Products, Inc., cleared under FDA 510(k) K161294 on 15 Sep 2016 and listed in FDA GUDID since 9 Feb 2017 (UDI-DI 00075137110854), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K161294

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00075137110854 UDI-DI Date9 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161294 Date15 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161294 decided 15 Sep 2016 Active
  • FDA GUDID UDI-DI 00075137110854 listed 9 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161294
  2. Listed FDA GUDID 00075137110854

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Wart-removal cryogenic kit
Model / Ref / Catalog
CW067601, CW067201, CW067202, CW068101 (First Aid)
Primary DI / UDI-DI
00075137110854
510(k) Number
FDA product code
GEH
GMDN term
Wart-removal cryogenic kit
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wart-removal cryogenic kit

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Other devices from Medtech Products, Inc.

See all devices from Medtech Products, Inc. →

Properties

  • Over-the-counter
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)