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InZone Detachment System

by Stryker Neurovascular 2 variants

510(k) K212455

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 NumberK212455 Date16 Nov 2021ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2552-2026 FDA Class II initiated 6 Apr 2026

    Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

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  • Withdrawn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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