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FDA 510(k)

EARP Nerve Cuff Electrode

K-Number: K230853 · 2023-10-06

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2023-10-06
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EARP Nerve Cuff Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230853. 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 EARP Nerve Cuff Electrode?

EARP Nerve Cuff Electrode is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K230853.

When did EARP Nerve Cuff Electrode receive FDA 510(k) clearance?

EARP Nerve Cuff Electrode received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230853.

Who is the listed applicant for EARP Nerve Cuff Electrode?

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

What is the FDA product code for EARP Nerve Cuff Electrode?

The FDA product code for EARP Nerve Cuff Electrode is ETN.

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NCT06204900A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.COMPLETED

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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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