Evala Nerve Stimulator (EPNR002)— 510(k) K253536
Substantially EquivalentEpineuron Technologies, Inc.
FDA 510(k) clearance K253536 for Evala Nerve Stimulator (EPNR002), Substantially Equivalent on 2026-02-27. Applicant: Epineuron Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Epineuron Technologies, Inc.
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
Recent devices under product code ETN
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- K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
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Adverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
Source: openFDA MAUDE database, through . 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.