510(k) Report

Devices descending from K013274

26 later devices reach Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082097Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureDemetech Corp.20104—
+1K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions20037—
+1K030212Monodek Synthetic Absorbable Surgical SutureGenzyme Biosurgery2003123
+2K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…Lsi Solutions, Inc.20200—
+2K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation20190—
+2K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+2K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation20182—
+2K120284Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with…Coloplast A/S201201
+2K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc.20105—
+3K254238MINT MONO SuturesHans Biomed Corporation20260—
+3K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+3K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+3K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.20250—
+3K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc.20240—
+3K230311HyperSutureThreadstone, LLC20234—
+3K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+3K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions20161—
+3K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC20151—
+4K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+4K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+4K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+4K234079HyperSuture Extension LineThreadstone, LLC20240—
+4K210675EasyWhipWinter Innovations, Inc.20211—
+4K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions20200—
+4K150882Edwards Suture Fastening SystemEdwards Lifesciences, LLC201501
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—