510(k) K213283

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter by Convatec Limited — Product Code GBM

K213283 is an FDA 510(k) premarket notification submitted by Convatec Limited for the device "GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter". The FDA issued a decision of Substantially Equivalent on June 22, 2022. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Convatec Limited has at least 9 other 510(k) clearances on record.