510(k) Report

Devices descending from K151084

19 later devices reach Well Lead Ureteral Access Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan)20235—
+1K203165Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd.20214—
+1K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20167—
+2K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+2K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.20250—
+2K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.20250—
+2K243710Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd.20251—
+2K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America20251—
+2K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.20250—
+2K240167Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.20241—
+2K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited20242—
+2K220065Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.20221—
+2K203119ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20200—
+2K200419Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.20200—
+3K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.20260—
+3K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…Zhuhai Pusen Medical Technology Co., Ltd.20260—
+3K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—
+3K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+3K250585LumenaTM Ureteral Access SheathCathegenix (Xiamen) Co., Ltd.20250—