510(k) Report

Devices descending from K102485

27 later devices reach RE-Trace Ureteral Access Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140523RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CMColoplast A/S20145—
+1K123675RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access…Coloplast A/S201322—
+2K181811ReTrace Ureteral Access SheathColoplast A/S20181—
+2K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated20172—
+2K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd.201619—
+3K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.20250—
+3K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…Coloplast Corp.20240—
+3K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan)20235—
+3K203165Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd.20214—
+3K182403Peel-Away IntroducerCook Incorporated20190—
+3K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20167—
+4K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+4K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.20250—
+4K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.20250—
+4K243710Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd.20251—
+4K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America20251—
+4K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.20250—
+4K240167Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.20241—
+4K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited20242—
+4K220065Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.20221—
+4K203119ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20200—
+4K200419Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.20200—
+5K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.20260—
+5K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…Zhuhai Pusen Medical Technology Co., Ltd.20260—
+5K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—
+5K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+5K250585LumenaTM Ureteral Access SheathCathegenix (Xiamen) Co., Ltd.20250—