K062413 is an FDA 510(k) clearance for the AESCULAP PNEUMATIC KERRISON. This device is classified as a Rongeur, Powered (Class II - Special Controls, product code HAD).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 21, 2006, 96 days after receiving the submission on August 17, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4845.
| 510(k) Number | K062413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2006 |
| Decision Date | November 21, 2006 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAD — Rongeur, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4845 |