510(k) Report

Devices descending from K061425

14 later devices reach Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191878DEX DeviceDex Surgical20210—
+1K173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)Lumendi, LLC20181—
+1K173919HX DeviceHuman Extension, Ltd.20188—
+1K111412Surgisteer Scissors, Surgisteer Dissector / Grasper, Surgisteer HookSteerable Technologix20110—
+1K072811Marionette SA, Model 001 001 & 001 002Kinetic Surgical, LLC20080—
+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—
+2K183112DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)Lumendi, LLC20190—
+3K230491HandX™ Monopolar ScissorsHuman Xtensions, Ltd.20230—
+3K222011HandX Instrument - Monopolar SpatulaHuman Xtensions, Ltd.20230—