510(k) K203637

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) by Coloplast — Product Code EZD

K203637 is an FDA 510(k) premarket notification submitted by Coloplast for the device "SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)". The FDA issued a decision of Substantially Equivalent on Mar 8, 2022. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Coloplast has 139 other 510(k) clearances on record.