510(k) Report

Devices descending from K000037

94 later devices reach Monofilament Biosyn Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic20260—
+1K211792StitchKitOrigami Surgical Inc .20211—
+1K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+1K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+1K013671L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc200243—
+2K221527StitchKitOrigami Surgical Inc .20230—
+2K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+2K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+2K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012191
+2K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+2K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+2K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+2K042141Polyglytone 6211 Synthetic Absorbable SutureTeleflex Medical200411—
+2K040477MonodermSurgical Specialties Corp200429—
+2K032586Caprosyn Absorbable SutureUnited States Surgical, A Division of Tyco Healthc200312—
+3K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+3K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+3K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+3K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+3K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+3K202950StitchKit COMBOOrigami Surgical20212—
+3K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+3K191070Signia Small Diameter ReloadsCovidien201927
+3K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+3K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+3K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+3K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+3K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+3K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+3K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+3K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+3K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+3K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+3K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+3K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation201410—
+3K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+3K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+3K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+3K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+3K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+3K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+3K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201218—
+3K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+3K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+3K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp200528—
+4K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+4K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+4K230311HyperSutureThreadstone, LLC20234—
+4K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+4K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+4K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.20220—
+4K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+4K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+4K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+4K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+4K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+4K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+4K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+4K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+4K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+4K160176Signia StaplerCovidien2016514
+4K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.201581
+4K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+4K140227Monoderm Surgical SutureSurgical Specialties Corp20140—
+4K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+4K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+4K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+4K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+4K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+4K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+4K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726—
+5K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+5K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+5K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+5K234079HyperSuture Extension LineThreadstone, LLC20240—
+5K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+5K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+5K210675EasyWhipWinter Innovations, Inc.20211—
+5K202864Tri-Staple 2.0 ReloadsCovidien20201—
+5K201672Signia Stapler (with new software)Covidien20200—
+5K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+5K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+5K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+5K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+5K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+6K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+6K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+6K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+6K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+6K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—
+6K233355Cypris eXact Suturing SystemCypris Medical20240—
+6K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+6K211178DURAMESH Mesh SutureMsi20220—
+6K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011