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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 the device name listed in this FDA 510(k) record. The listed applicant is Epineuron Technologies, Inc.. It received FDA 510(k) clearance on 2026-02-27 under 510(k) 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. The listed applicant is Epineuron Technologies, Inc.. The 510(k) number is K253536.

When did Evala Nerve Stimulator (EPNR002) receive FDA 510(k) clearance?

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

Who is the listed applicant for Evala Nerve Stimulator (EPNR002)?

The FDA 510(k) record lists Epineuron Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: ETN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)Medtronic Xomed, Inc.K242852ALM 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)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLCK232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd.K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeMedtronic 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.

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