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K Number
K252910Device Name
Orca Air/Water and Suction ValvesManufacturer
Date Cleared
2025-10-09
(27 days)
Product Code
Regulation Number
876.1500Type
SpecialReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
The Orca Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Device Description
Orca Air/Water and Suction Valves are endoscopic channel accessories that attach to the Air/Water and Suction ports on the endoscope handle to control the amount of air/water flow and suction of an endoscope.
AI/ML Overview
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