510(k) K090851

DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) by Byrne Medical, Inc. — Product Code ODC

K090851 is an FDA 510(k) premarket notification submitted by Byrne Medical, Inc. for the device "DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)". The FDA issued a decision of Substantially Equivalent on July 2, 2009. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. Byrne Medical, Inc. has at least 10 other 510(k) clearances on record.