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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K252910
Device Name Orca Air/Water and Suction Valves
Applicant
Boston Scientific
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Claire Paddock
Correspondent
Boston Scientific
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Claire Paddock
Regulation Number876.1500
Classification Product Code
ODC  
Date Received09/12/2025
Decision Date 10/09/2025
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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