K212455 is an FDA 510(k) clearance for the InZone Detachment System. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on November 16, 2021, 103 days after receiving the submission on August 5, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K212455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2021 |
| Decision Date | November 16, 2021 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCG — Device, Neurovascular Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5950 |