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510(k) Data Aggregation
K Number
K110088Device Name
DEFENDO Y-OPSY IRRIGATOR
Manufacturer
BYRNE MEDICAL INCORPORATED
Date Cleared
2011-06-10
(149 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BYRNE MEDICAL INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEFENDO™ Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
Device Description
The DEFENDO™Y-Opsy Irrigator is a sterile, disposable, single patient use, biopsy valve with a side port backflow valve for irrigation. It provides access for endoscopic device passage, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy channel during endoscopic procedures. The backflow valve prevents the potential of cross contamination between patients the device's diaphragm (slit) minimizes leakage from the biopsv channel while reducing the healthcare professional's exposure to biomaterials as endoscopy instruments are withdrawn.
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