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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K230125
Device Name Neuroblade System
Applicant
Clearmind Biomedical
5f, # 167, Fuxing N. Rd., Songshan Dist.
Taipei,  TW 105403
Applicant Contact Vance Lin
Correspondent
Coombs Medical Device Consulting, Inc.
1100 Pacific Marina, Suite #806
Alameda,  CA  94501
Correspondent Contact Craig Coombs
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Code
GEI  
Date Received01/17/2023
Decision Date 10/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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