510(k) K180469

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent by Coloplast Corp. — Product Code FAD

K180469 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent". The FDA issued a decision of Substantially Equivalent on Nov 6, 2018. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Coloplast Corp. has 139 other 510(k) clearances on record.