K253536
- 510(k) number
- K253536
- Device name
- Evala Nerve Stimulator (EPNR002)
- Applicant
- Epineuron Technologies, Inc. CA
- Product code
- ETN — Stimulator, Nerve
- Decision date
- 2026-02-27
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253536.pdf
Official FDA record: K253536
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.