510(k) K253536
K253536 is an FDA 510(k) premarket notification submitted by Epineuron Technologies, Inc. for the device "Evala Nerve Stimulator (EPNR002)". The FDA issued a decision of Substantially Equivalent on February 27, 2026. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2026
- Date Received
- November 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type