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Equate 432306

by Walmart Stores

Equate 432306 is a Class II device made by Walmart Stores, cleared under FDA 510(k) K210529 on 6 May 2021 and listed in FDA GUDID since 12 Nov 2024 (UDI-DI 00194346320776), 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) K210529

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 Number00194346320776 UDI-DI Date12 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210529 Date6 May 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210529 decided 6 May 2021 Active
  • FDA GUDID UDI-DI 00194346320776 listed 12 Nov 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210529
  2. Listed FDA GUDID 00194346320776

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Equate
Generic name
Cryogenic spray, cutaneous
Model / reference
432306
Primary DI / UDI-DI
00194346320776
FDA product code
GEH
GMDN term
Cryogenic spray, cutaneous
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution

Similar devices

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

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Properties

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