510(k) Report

Devices descending from K993650

11 later devices reach Ureteral Access Sheath Set - New Models through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation200552
+1K043418Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc.200541
+1K030642Deflecting Ureteral Access SheathApplied Medical Resources Corp.20031—
+2K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated20172—
+2K123170Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America20131—
+2K120160Rocamed Rocaus PlatinumPromepla Sam20122—
+2K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc.200701
+3K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.20250—
+3K182403Peel-Away IntroducerCook Incorporated20190—
+3K140441BI-Flex Ureteral Access SheathPromepla Sam20141—
+4K182144Bi-Flex EvoPromepla Sam20180—