510(k) K252943

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women by Convatec Limited — Product Code EZD

K252943 is an FDA 510(k) premarket notification submitted by Convatec Limited for the device "GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women". The FDA issued a decision of Substantially Equivalent on April 1, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Convatec Limited has at least 9 other 510(k) clearances on record.