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Busse Hospital Disposables Spinal Manometer

by Busse Hospital Disposables, Inc.

510(k) K032432

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032432 Date28 Aug 2003ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0541-2018 FDA Class II initiated 27 Jun 2017 on shared 510(k) K032432
    • Terminated Z-0546-2018 FDA Class II initiated 27 Jun 2017 on shared 510(k) K032432
    • Terminated Z-0543-2018 FDA Class II initiated 27 Jun 2017 on shared 510(k) K032432
    • Terminated Z-0544-2018 FDA Class II initiated 27 Jun 2017 on shared 510(k) K032432
    • Terminated Z-0542-2018 FDA Class II initiated 27 Jun 2017 on shared 510(k) K032432
    • Terminated Z-0540-2018 FDA Class II initiated 27 Jun 2017 on shared 510(k) K032432
    • Terminated Z-0545-2018 FDA Class II initiated 27 Jun 2017 on shared 510(k) K032432

    BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
FMJ
Device Class
Class II
Regulation
21 CFR Part 880.2500
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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