510(k) Report

Devices descending from K161110

7 later devices reach ClearPetra Suction-Evacuation Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation20260—
+1K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.20250—
+1K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America20251—
+1K243025Ureteral Access SheathSeplou (Zhuhai) Co., Ltd.20250—
+1K203119ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd.20200—
+1K200419Kalera Vacuum Aspiration Catheter (K-VAC)Kalera Medical, Inc.20200—
+2K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.20250—