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Target Detachable Coils

by Stryker Neurovascular 2 variants

510(k) K153658

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

28 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 NumberK153658 Date19 May 2016ClearedStatusActive

Recalls

28 recalls · FDA

  • 28 recalls, same reason

    • Terminated Z-2160-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2171-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2172-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2182-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2170-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2183-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2176-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2179-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2161-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2187-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2181-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2175-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2178-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2167-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2168-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2186-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2185-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2177-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2173-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2184-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2180-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2163-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2165-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2164-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2162-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2169-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2174-2016 FDA Class II initiated 6 Jun 2016
    • Terminated Z-2166-2016 FDA Class II initiated 6 Jun 2016

    Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.

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
HCG
Device Class
Class II
Regulation
21 CFR Part 882.5950
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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