510(k) Report

Devices descending from K896053

21 later devices reach All Silicone Foley Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981612All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…Rochester Medical Corp.199819—
+1K971627Silicone Antibacterial Foley CatheterRochester Medical Corp.19980—
+2K130908Disposable Silicone Foley CatheterGuangdong Baihe Medical Technology Co., Ltd.20136—
+2K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc.20091—
+2K082815Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments200810—
+2K013276All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd.20022—
+3K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd.20241—
+3K201776Foley Balloon Catheter for UrologyApollon Co., Ltd.20200—
+3K182463Silicone Foley CatheterBiosensors International Pte, Ltd.20190—
+3K181616PSM 3-Way Silicone Foley CatheterPathway, LLC20180—
+3K173657Radiance (TM) Clear Sharklet (R) Silicone Foley CatheterCook Incorporated20180—
+3K172807Silicone Foley Catheter for single useChangzhou Rongxin Medicine Minimal Invasion Technology20180—
+3K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated20170—
+3K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex…Zhanjiang Star Enterprise Co., Ltd.20170—
+3K161770Rusch Silicone Foley CatheterTeleflexmedical, Inc.20170—
+3K142635Medline Silicone Foley CatheterMedline Industries, Inc.201511
+3K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+3K091516Well Lead Silicone Catheter with Temperature SensorWell Lead Medical Co., Ltd.20091—
+4K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.20250—
+4K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC20240—
+4K202134Well Lead All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co., Ltd.20210—