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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 K253679
Device Name Hydro Irrigation System
Applicant
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Divya Sekar
Correspondent
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Divya Sekar
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Codes
EOB   ERL  
Date Received11/21/2025
Decision Date 05/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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