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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 K250752
Device Name AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
Applicant
Integra LifeSciences Corporation
1100 Campus Rd.
Princeton,  NJ  08540
Applicant Contact Rebecca Odulio
Correspondent
Integra LifeSciences Corporation
1100 Campus Rd.
Princeton,  NJ  08540
Correspondent Contact Rebecca Odulio
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Code
GZT  
Date Received03/12/2025
Decision Date 04/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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