FDA 510(k) Applications Submitted by ConvaTec Limited

FDA 510(k) Number Submission Date Device Name Applicant
K152926 10/05/2015 AQUACEL Ag Surgical SP Dressing CONVATEC LIMITED
K181206 05/07/2018 GentleCath Glide Intermittent Urinary Catheter ConvaTec Limited
K161344 05/13/2016 GentleCath Glide Intermittent Catheter CONVATEC LIMITED
K172924 09/25/2017 GentleCath Intermittent Urinary Catheter ConvaTec Limited
K180205 01/24/2018 AVELLE Negative Pressure Wound Therapy System ConvaTec Limited
K173675 11/30/2017 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber ConvaTec Limited
K190114 01/24/2019 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) ConvaTec Limited
K213283 10/01/2021 GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter ConvaTec Limited


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