Evala Nerve Stimulator (EPNR002)
FDA 510(k) clearance K253536 · decided 2026-02-27
Clearance details
- K-number
- K253536
- Device name
- Evala Nerve Stimulator (EPNR002)
- Applicant
- Epineuron Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-13
- Decision date
- 2026-02-27
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Epineuron Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.