K071931 is an FDA 510(k) clearance for the CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223. This device is classified as a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II - Special Controls, product code HBF).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 22, 2007, 101 days after receiving the submission on July 13, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4305.
| 510(k) Number | K071931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2007 |
| Decision Date | October 22, 2007 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBF - Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4305 |