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Neurological Sponges (Patties)

by Carwild Corp.

510(k) K791871

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK791871 Date5 Nov 1979ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2639-2026 FDA Class II initiated 7 May 2026

    Due to out-of-specification, or potential out-of-specification, levels of endotoxins

    • Terminated Z-0772-2023 FDA Class II initiated 28 Sep 2022

    Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EFQ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Other devices from Carwild Corp.