510(k) K061009

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS by Onset Medical Corporation — Product Code EZN

K061009 is an FDA 510(k) premarket notification submitted by Onset Medical Corporation for the device "PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS". The FDA issued a decision of Substantially Equivalent on May 2, 2006. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Onset Medical Corporation has at least 7 other 510(k) clearances on record.