K082010 is an FDA 510(k) clearance for the STRYKER DISPOSABLE CRANIAL PERFORATOR BIT. This device is classified as a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II - Special Controls, product code HBF).
Submitted by Stryker Ireland Ltd., Instruments Division (Carrigtwohill, Co.Cork, IE). The FDA issued a Cleared decision on December 29, 2008, 167 days after receiving the submission on July 15, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4305.
| 510(k) Number | K082010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2008 |
| Decision Date | December 29, 2008 |
| Days to Decision | 167 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 |