510(k) Report

Devices descending from K000070

21 later devices reach Flocath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.20190—
+1K183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…Teleflexmedical, Inc.20196—
+1K181206GentleCath Glide Intermittent Urinary CatheterConvatec Limited20183—
+1K161344GentleCath Glide Intermittent CatheterConvatec Limited20164—
+1K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S.20075—
+1K013345Incare Intermittent CatheterHollister, Inc.20021—
+2K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical20260—
+2K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec Limited20260—
+2K251274EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…HR Healthcare20260—
+2K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…Convatec20241—
+2K223756SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona20230—
+2K212567PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd.20220—
+2K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited20221—
+2K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd.20203—
+2K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20142—
+2K112137Comfortglide Intermitent CatheterC.R. Bard, Inc.20110—
+3K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.20260—
+3K243175Disposable Intermittent Catheter (TPU Catheter)Chengdu Daxan Innovative Medical Tech. Co., Ltd.20250—
+3K220722PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20230—
+3K222677Intermittent nelaton catheter for single useHangzhou Jimushi Meditech Co., Ltd.20230—
+3K142563Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd.20140—