510(k) K213444

RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm by Ureteral Stent Company — Product Code FAD

K213444 is an FDA 510(k) premarket notification submitted by Ureteral Stent Company for the device "RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm". The FDA issued a decision of Substantially Equivalent on March 17, 2022. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Ureteral Stent Company has at least 1 other 510(k) clearance on record.