K073336 is an FDA 510(k) clearance for the CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231. 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 January 4, 2008, 37 days after receiving the submission on November 28, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4305.
| 510(k) Number | K073336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2007 |
| Decision Date | January 04, 2008 |
| Days to Decision | 37 days |
| Submission Type | Special |
| 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 |