Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Evala Nerve Stimulator (EPNR002)

K-Number: K253536 · 2026-02-27

ApplicantEpineuron Technologies, Inc.
Decision Date2026-02-27
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Evala Nerve Stimulator (EPNR002) is a medical device manufactured by Epineuron Technologies, Inc.. It received FDA 510(k) clearance on 2026-02-27 under approval number K253536. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evala Nerve Stimulator (EPNR002)?

Evala Nerve Stimulator (EPNR002) is a medical device that received FDA 510(k) clearance on 2026-02-27. It is manufactured by Epineuron Technologies, Inc.. The 510(k) number is K253536.

When was Evala Nerve Stimulator (EPNR002) approved by the FDA?

Evala Nerve Stimulator (EPNR002) received FDA 510(k) clearance on 2026-02-27, under approval number K253536.

What company makes Evala Nerve Stimulator (EPNR002)?

Evala Nerve Stimulator (EPNR002) is manufactured by Epineuron Technologies, Inc..

What is the FDA product code for Evala Nerve Stimulator (EPNR002)?

The FDA product code for Evala Nerve Stimulator (EPNR002) is ETN.

Related Clinical Trials

NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT01581580 Deep Brain Stimulation Surgery for Movement Disorders RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT06796504 The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study RECRUITING NCT07569705 Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients RECRUITING NCT07543302 Can External Vagus Nerve Stimulation Reduce Systemic Levels of Inflammatory Mediators in Duchenne Muscular Dystrophy Patients? ENROLLING_BY_INVITATION

Related Devices (Code: ETN)

K152769FREMAP ELECTRODEAd-Tech Medical Instrument Corporation K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH K200886StimSiteAllotrope Medical, Inc. K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical K212164Mapping Suction ProbeInomed Medizintechnik GmbH K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongMedtronic Xomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑