510(k) Report

Devices descending from K963999

23 later devices reach Auto Suture* Modified Endoscopic Fascia Stapler** Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien2009122
+1K081366Kumar T-Anchors Hernia SetNashville Surgical Instruments20081—
+1K013749Endoanchor and OpenanchorEthicon Endo-Surgery, Inc.20027—
+2K231240MaxTack™ Motorized Fixation DeviceCovidien20230—
+2K173917neoClose PDSNeosurgical, Ltd.20180—
+2K142808CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation…C.R. Bard, Inc.20151—
+2K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+2K123109Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien20124—
+2K111048Synthes Scout Tack FixationSynthes Spine20120—
+2K110728Imesh TackerEasylap, Ltd.20111—
+2K061276G-Prox Endoscopic GrasperUsgi Medical20065—
+2K023372Non-Bioabsorbable StapleOnux Medical, Inc.20026—
+3K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…C.R. Bard, Inc.20171—
+3K160900CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure…C.R. Bard, Inc.20160—
+3K153202iMESH TackerThd Lap20160—
+3K140609Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble TacksCovidien20141—
+3K102931G-Cinch Suture GrasperUsgi Medical20100—
+3K102916G-Cath Tissue Anchor Delivery CatheterUsgi Medical20100—
+3K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical20101—
+3K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical20091—
+4K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners…Davol Inc., Subsidiary of C.R. Bard20190—
+4K151659ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable TacksCovidien, LLC20150—
+4K103688G-Prox EZ Endoscopic GrasperUsgi Medical20110—