510(k) K082805

PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX by Q Urological Corporation — Product Code FAD

K082805 is an FDA 510(k) premarket notification submitted by Q Urological Corporation for the device "PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX". The FDA issued a decision of Substantially Equivalent on Jan 20, 2010. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Q Urological Corporation has 2 other 510(k) clearances on record.