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Stryker Disposable Cranial Perforator Bit

by Stryker Ireland Ltd., Instruments Division

510(k) K082010

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK082010 Date29 Dec 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0431-2021 FDA Class II initiated 16 Oct 2020

    Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment 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  • Withdrawn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
HBF
Device Class
Class II
Regulation
21 CFR Part 882.4305
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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