510(k) Report

Devices descending from K161344

4 later devices reach GentleCath Glide Intermittent Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181206GentleCath Glide Intermittent Urinary CatheterConvatec Limited20183—
+2K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec Limited20260—
+2K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…Convatec20241—
+2K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited20221—