K253536 is an FDA 510(k) clearance for the Evala Nerve Stimulator (EPNR002). This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).
Submitted by Epineuron Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 27, 2026, 106 days after receiving the submission on November 13, 2025.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.
| 510(k) Number | K253536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2025 |
| Decision Date | February 27, 2026 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETN — Stimulator, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |