510(k) K170531

Ureteral Dilators and Percutaneous Nephrostomy Dilators by Coloplast Corp. — Product Code EZN

K170531 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Ureteral Dilators and Percutaneous Nephrostomy Dilators". The FDA issued a decision of Substantially Equivalent on August 17, 2017. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Coloplast Corp. has at least 10 other 510(k) clearances on record.