Evala Nerve Stimulator (EPNR002)— 510(k) K253536

Substantially Equivalent

Epineuron Technologies, Inc.

FDA 510(k) clearance K253536 for Evala Nerve Stimulator (EPNR002), Substantially Equivalent on 2026-02-27. Applicant: Epineuron Technologies, Inc..

Clearance details

Applicant: Epineuron Technologies, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2025-11-13
Decision date: 2026-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.