510(k) Report

Devices descending from K981612

19 later devices reach All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… through their predicates, nearest generation first.

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