K912456 is an FDA 510(k) clearance for the SUNDT SLIM-LINE GRAFT CLIPS. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on March 10, 1995, 1376 days after receiving the submission on June 3, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K912456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1991 |
| Decision Date | March 10, 1995 |
| Days to Decision | 1376 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HCH - Clip, Aneurysm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5200 |