510(k) Report

Devices descending from K030956

33 later devices reach Navigator Ureteral Access Sheath Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122649Navigator HD Ureteral Access Sheath SetBoston Scientific Corp201224—
+1K120160Rocamed Rocaus PlatinumPromepla Sam20122—
+1K043418Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc.200541
+2K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated20172—
+2K160861Proxis Ureteral Access SheathC.R. Bard, Inc.20161—
+2K140441BI-Flex Ureteral Access SheathPromepla Sam20141—
+2K140323Navigator HD Ureteral Access Sheath SetsBoston Scientific201421—
+2K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc.200701
+3K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.20250—
+3K250517Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD…Boston Scientific Corporation20250—
+3K201815Dornier MAGELLAN Ureteral Access SheathDornier Medtech America, Inc.20200—
+3K182403Peel-Away IntroducerCook Incorporated20190—
+3K182144Bi-Flex EvoPromepla Sam20180—
+3K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd.201619—
+4K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan)20235—
+4K203165Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd.20214—
+4K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20167—
+5K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+5K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.20250—
+5K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.20250—
+5K243710Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd.20251—
+5K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America20251—
+5K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.20250—
+5K240167Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.20241—
+5K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited20242—
+5K220065Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.20221—
+5K203119ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20200—
+5K200419Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.20200—
+6K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.20260—
+6K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…Zhuhai Pusen Medical Technology Co., Ltd.20260—
+6K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—
+6K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.20250—
+6K250585LumenaTM Ureteral Access SheathCathegenix (Xiamen) Co., Ltd.20250—