510(k) K223821

Self-Cath Closed System by Coloplast — Product Code FCM

K223821 is an FDA 510(k) premarket notification submitted by Coloplast for the device "Self-Cath Closed System". The FDA issued a decision of Substantially Equivalent on August 2, 2023. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. Coloplast has at least 10 other 510(k) clearances on record.