510(k) Report

Devices descending from K961904

17 later devices reach AQ Hydrophilic Dilators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated20180—
+1K170531Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp.201711
+1K043418Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc.200541
+1K990808PBN DilatorsMedical Device Technologies, Inc.19992—
+1K981611Snap-N-Peel IntroducersCircon Corp.19986—
+2K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.20250—
+2K183036Dilator SetsCook Incorporated201813
+2K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated20172—
+2K123170Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America20131—
+2K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc.200701
+2K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation200552
+3K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.20250—
+3K210734Endovascular Dilator and SetsCook Incorporated20210—
+3K182403Peel-Away IntroducerCook Incorporated20190—
+3K120160Rocamed Rocaus PlatinumPromepla Sam20122—
+4K140441BI-Flex Ureteral Access SheathPromepla Sam20141—
+5K182144Bi-Flex EvoPromepla Sam20180—