K241917 is an FDA 510(k) clearance for the EARP Nerve Cuff Electrode. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Retropsoas Technologies, LLC (Frontenac, US). The FDA issued a Cleared decision on July 31, 2024, 30 days after receiving the submission on July 1, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K241917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2024 |
| Decision Date | July 31, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | ETN - Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |