K223596 is an FDA 510(k) clearance for the SQ.line KERRISON. This device is classified as a Rongeur, Manual (Class II - Special Controls, product code HAE).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on June 29, 2023, 209 days after receiving the submission on December 2, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4840.
| 510(k) Number | K223596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2022 |
| Decision Date | June 29, 2023 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAE — Rongeur, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4840 |