K221524 is an FDA 510(k) clearance for the Sugita AVM Microclip Applier. This device is classified as a Applier, Aneurysm Clip (Class II - Special Controls, product code HCI).
Submitted by Mizuho America, Inc. (Union City, US). The FDA issued a Cleared decision on June 24, 2022, 29 days after receiving the submission on May 26, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4175.
| 510(k) Number | K221524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2022 |
| Decision Date | June 24, 2022 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCI - Applier, Aneurysm Clip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4175 |