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FDA 510(k)

EARP Nerve Cuff Electrode

K-Number: K241917 · 2024-07-31

ApplicantRetropsoas Technologies, LLC
Decision Date2024-07-31
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 Retropsoas Technologies, LLC. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K241917. 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 2024-07-31. The listed applicant is Retropsoas Technologies, LLC. The 510(k) number is K241917.

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

EARP Nerve Cuff Electrode received FDA 510(k) clearance on 2024-07-31, under 510(k) number K241917.

Who is the listed applicant for EARP Nerve Cuff Electrode?

The FDA 510(k) record lists Retropsoas Technologies, LLC 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.

Related Clinical Trials

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.

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

Other records listing Retropsoas Technologies, LLC as applicant

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.

K242457EARP Interbody System

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.

K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.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.K232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd.K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeMedtronic Xomed, Inc.

Official Source

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