510(k) K213185

ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits by Coloplast Corp. — Product Code FAD

K213185 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits". The FDA issued a decision of Substantially Equivalent (kit) on June 8, 2022. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Coloplast Corp. has at least 10 other 510(k) clearances on record.