Submission Details
| 510(k) Number | K210741 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
KLS Martin Neuro Rongeurs
Jun 2022
Decision
448d
Days
Class 2
Risk
About This 510(k) Submission
K210741 is an FDA 510(k) clearance for the KLS Martin Neuro Rongeurs, 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 review panel. Regulated under 21 CFR 882.4840.
Device Classification
| Product Code | HAE — Rongeur, Manual |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4840 |
Manufacturer
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