510(k) K252910

Device
Orca Air/Water and Suction Valves
Applicant
Boston Scientific
510(k) number
K252910
Product code
ODC
Decision
Unknown (SESK)
Decision date
2025-10-09
Date received
2025-09-12
Regulation
876.1500
Classification name
Endoscope Channel Accessory
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Claire Paddock
Address
100 Boston Scientific Way Marlboro MA US 01752 01752

FDA Registration Numbers

Source Documents

510(k) summary PDF

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