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Iso-Gard Filter Angled(18212)/Iso-Gard Filter Straight(19212)

by Gibeck, Inc.

510(k) K965016

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 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 NumberK965016 Date2 Dec 1997ClearedStatusActive

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-0073-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0074-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0075-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0072-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0077-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0076-2023 FDA Class I initiated 29 Aug 2022

    Incidents of device splitting or detaching during use

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  • Withdrawn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
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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