K210741 is an FDA 510(k) clearance for the KLS Martin Neuro Rongeurs. This device is classified as a Rongeur, Manual (Class II - Special Controls, product code HAE).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on June 3, 2022, 448 days after receiving the submission on March 12, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4840.
| 510(k) Number | K210741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2021 |
| Decision Date | June 03, 2022 |
| Days to Decision | 448 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 |