510(k) Report

Devices descending from K032698

74 later devices reach Coapt Endotine Midface-ST 4.5 Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041835Endotine Midface B 4.5 DeviceCoapt Systems, Inc.20040—
+1K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp200472—
+2K091061Implicitguide Surgical Suture SystemImplicitcare, LLC20091—
+2K052962Optimized Barb DesignSurgical Specialties Corp20050—
+2K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp200565—
+2K050247Contour Necklift ThreadsSurgical Specialties Corp20053—
+2K042856Contour Forehead/Browlift ThreadSurgical Specialties Corp20044—
+3K230510MyEllevateCynosure, LLC20230—
+3K052373Quill Nonabsorbable Polypropylene Barbed SutureQuill Medical, Inc.200510—
+3K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.200564—
+3K051415Endotine RibbonCoapt Systems, Inc.20051—
+4K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+4K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+4K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A.20171—
+4K133420Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech20136—
+4K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+4K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+4K120827Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech201213—
+4K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech201225—
+4K113800Quill Quadrahelix Tissue-Closure DeviceAngiotech20123—
+4K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp200829—
+4K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp200830—
+4K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp200731—
+4K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726—
+4K060828Modification to Endotine RibbonCoapt Systems, Inc.20060—
+4K053380Contour Thread Synthetic Absorbable Pdo Barbed SutureSurgical Specialties Corp20063—
+4K052900Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc.20050—
+5K253879Monofix PdoSamyang Holdings Corporation20260—
+5K233355Cypris eXact Suturing SystemCypris Medical20240—
+5K211178DURAMESH Mesh SutureMsi20220—
+5K210871PDO Max Suture with Dual NeedlePdo Max, Inc.20210—
+5K202950StitchKit COMBOOrigami Surgical20212—
+5K201139WEGO-PDO Barbed SutureFoosin Medical Supplies Inc., Ltd.20200—
+5K192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC20200—
+5K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+5K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+5K190264ViolaMeditime Co., Ltd.20190—
+5K172602MiracuFeeltech Co., Ltd.20184—
+5K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc.20160—
+5K143413J+PRAS YOUNG'S ThreadY. Jacobs Medical, Inc.20150—
+5K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+5K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc.20158—
+5K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+5K132268Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation Dba Angiotech20130—
+5K130191MINTHans Biomed Corporation20135—
+5K123877Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201311—
+5K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201218—
+5K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012191
+5K113004PDS (TM) Barbed SuturesETHICON, Inc.201111
+5K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+5K093408V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare200901
+5K073614WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.20082—
+6K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+6K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.20250—
+6K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd.20241—
+6K211792StitchKitOrigami Surgical Inc .20211—
+6K200392RexsinSm Eng Co., Ltd.20200—
+6K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation20190—
+6K190245PDS Barbed Suture, PDO MAXX ThreadsPdo Max, Inc.20190—
+6K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+6K173779Rexmono, PdrexSm Eng Co., Ltd.20180—
+6K162366Omega VLOv World Co., Ltd.20180—
+6K160761DW-1CDongwon Medical Co., Ltd.20161—
+6K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.201581
+6K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation201410—
+6K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+7K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+7K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd.20240—
+7K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+7K221527StitchKitOrigami Surgical Inc .20230—
+7K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+7K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.20220—
+7K190437Delta 3300Netech Corporation20190—
+8K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—