510(k) Report

Devices descending from K130908

6 later devices reach Disposable Silicone Foley Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201776Foley Balloon Catheter for UrologyApollon Co., Ltd.20200—
+1K182463Silicone Foley CatheterBiosensors International Pte, Ltd.20190—
+1K172807Silicone Foley Catheter for single useChangzhou Rongxin Medicine Minimal Invasion Technology20180—
+1K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated20170—
+1K170233Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex…Zhanjiang Star Enterprise Co., Ltd.20170—
+1K161770Rusch Silicone Foley CatheterTeleflexmedical, Inc.20170—