510(k) K212455 ยท HCG Device, Neurovascular Embolization
InZone Detachment System
| Applicant | Stryker Neurovascular, Fremont CA, US |
| Decision | Substantially Equivalent, Nov 16, 2021 |
| Received | Aug 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | Stryker Neurovascular INZONE DETACHMENT SYSTEM, REF: M00345100950 Open, Classified |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.