K902544 is an FDA 510(k) clearance for the SUNDT AVM MICRO CLIP. This device is classified as a Applier, Aneurysm Clip (Class II - Special Controls, product code HCI).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on September 20, 1990, 106 days after receiving the submission on June 6, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4175.
| 510(k) Number | K902544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1990 |
| Decision Date | September 20, 1990 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | HCI - Applier, Aneurysm Clip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4175 |