K230853 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 Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on October 6, 2023, 192 days after receiving the submission on March 28, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K230853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2023 |
| Decision Date | October 06, 2023 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |