510(k) K190312

Dornier Ureteral Stent by Dornier Medtech America, Inc. — Product Code FAD

K190312 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "Dornier Ureteral Stent". The FDA issued a decision of Substantially Equivalent on November 15, 2019. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.