510(k) Report

Devices descending from K123102

13 later devices reach Sovereign Mini through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173919HX DeviceHuman Extension, Ltd.20188—
+1K160393AdTecAesculap, Inc.20160—
+1K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc.201522
+2K260183MediBot Needle Driver UnoParallel Robotics, LLC20260—
+2K243968Revolve Surgical SystemRevolve Surgical, Inc.20250—
+2K244029Robopera (ER-R-002); Robopera (ER-R-003)Endorobotics Co., Ltd.20250—
+2K223718HandX™ Self-Righting Needle HolderHuman Xtensions, Ltd.20230—
+2K212214HandXHuman Xtensions, Ltd.20210—
+2K203603Monopolar HookHuman Xtensions, Ltd.20213—
+2K153063Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc.201619
+3K230491HandX™ Monopolar ScissorsHuman Xtensions, Ltd.20230—
+3K222011HandX Instrument - Monopolar SpatulaHuman Xtensions, Ltd.20230—
+3K181852Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc.20180—