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510(k) Data Aggregation
K Number
K122417Device Name
SCOPEVALET DISPOSABLE BIOPSY VALVE
Manufacturer
THE RUHOF CORP.
Date Cleared
2013-05-17
(282 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
THE RUHOF CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ScopeValet Disposable Biopsy Valves, Model Numbers 345BVO and 345BVP, are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
Device Description
The Ruhof Corporation ScopeValet Disposable Biopsy Valves can be manufactured with a choice of two types - regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.
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