510(k) K170010

Salle Intraoperative Pyeloplasty Stent Set by Cook Incorporated — Product Code FAD

K170010 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Salle Intraoperative Pyeloplasty Stent Set". The FDA issued a decision of Substantially Equivalent on Aug 28, 2017. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cook Incorporated has 174 other 510(k) clearances on record.