510(k) K181206

GentleCath Glide Intermittent Urinary Catheter by Convatec Limited — Product Code GBM

K181206 is an FDA 510(k) premarket notification submitted by Convatec Limited for the device "GentleCath Glide Intermittent Urinary Catheter". The FDA issued a decision of Substantially Equivalent on August 16, 2018. 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.