510(k) K233411

Folysil Silicone Catheter by Coloplast Corp. — Product Code EZL

K233411 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Folysil Silicone Catheter". The FDA issued a decision of Substantially Equivalent on April 15, 2024. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Coloplast Corp. has at least 10 other 510(k) clearances on record.