510(k) Report

Devices descending from K012317

52 later devices reach Coalescent Surgical U-Clip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc.20105—
+1K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+1K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+1K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular20051—
+1K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20040—
+1K032896Anson Refix Vascular and Tissue Clip, Models GF-04-01 and GF-04-02Anson Medical, Ltd.20040—
+1K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical2003324
+1K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical2003411
+1K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical200242—
+1K013664Coalescent Surgical U-ClipCoalescent Surgical200244—
+2K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc.20240—
+2K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions20161—
+2K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC20151—
+2K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+2K062821U-Clip DeviceMedtronic Neurosurgery20060—
+2K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050Cardica, Inc.20057—
+2K033324Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20047—
+2K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical200243—
+3K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions20200—
+3K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+3K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+3K150882Edwards Suture Fastening SystemEdwards Lifesciences, LLC201501
+3K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+3K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+3K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+3K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200751
+3K053524C-Port Distal Anastomosis SystemCardica, Inc.200661
+3K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20052—
+3K043115Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd.20045—
+3K041751Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20046—
+4K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20251—
+4K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+4K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+4K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+4K093661ColonringNiti Surgical Solutions, Ltd.20110—
+4K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200911
+4K073304Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change SubassembliesCardica, Inc.20070—
+4K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.200711
+4K062008Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20061—
+5K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20260—
+5K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+5K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc.201001
+5K073123Cardica C-Port Flex-a Distal Anastomosis System, Model FG-000150Cardica, Inc.200701
+6K180010AtriClip FLEX-VAtriCure, Inc.20188—
+7K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+8K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+9K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+10K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+10K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+10K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+11K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+11K232295LAA Exclusion SystemSyntheon, LLC20231—