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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K261833
Device Name NEUROMARK System (NMK00301)
Applicant
Neurent Medical , Ltd.
Oranpoint, Main St., Oranmore
Galway,  IE H91 D7X2
Applicant Contact Fay Dalton
Correspondent
Neurent Medical , Ltd.
Oranpoint, Main St., Oranmore
Galway,  IE H91 D7X2
Correspondent Contact Fay Dalton
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/02/2026
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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