510(k) K171043

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters by Coloplast Corp. — Product Code EYB

K171043 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters". The FDA issued a decision of Substantially Equivalent on December 21, 2017. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Coloplast Corp. has at least 10 other 510(k) clearances on record.