510(k) Report

Devices descending from K140523

5 later devices reach RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181811ReTrace Ureteral Access SheathColoplast A/S20181—
+1K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated20172—
+2K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.20250—
+2K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…Coloplast Corp.20240—
+2K182403Peel-Away IntroducerCook Incorporated20190—