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.
Summary
Epineuron Technologies filed the Evala Nerve Stimulator (EPNR002) under product code ETN (Stimulator, Nerve). The record gives no further description of the device.
Class II, 21 CFR 874.1820. Ear, Nose, Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Epineuron Technologies filed from Mississauga, Canada. The decision came 106 calendar days after FDA received it (November 13, 2025 to February 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Epineuron Technologies, Inc.
- Product code
- Product 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
view all- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- 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)
- K233001 — Bioscope Neuromonitor Device
- K241917 — EARP Nerve Cuff Electrode
- K232888 — Disposable Laryngeal Electrodes
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.