K881912 is an FDA 510(k) clearance for the SANO CLIP APPLIERS & REMOVERS. This device is classified as a Applier, Aneurysm Clip (Class II - Special Controls, product code HCI).
Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on June 6, 1988, 28 days after receiving the submission on May 9, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4175.
| 510(k) Number | K881912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1988 |
| Decision Date | June 06, 1988 |
| Days to Decision | 28 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 |