K960037 is an FDA 510(k) clearance for the SUGITA AVM MICROCLIP. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Mizuho America, Inc. (Beverly, US). The FDA issued a Cleared decision on February 5, 1997, 399 days after receiving the submission on January 3, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K960037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1996 |
| Decision Date | February 05, 1997 |
| Days to Decision | 399 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCH - Clip, Aneurysm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5200 |