510(k) Report

Devices descending from K981582

27 later devices reach Surgilon, Dermalon, & Ophthalon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+1K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production201112—
+1K062821U-Clip DeviceMedtronic Neurosurgery20060—
+1K060471FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH200610—
+1K032160Artelon Surgical SutureArtimplant AB20031—
+2K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production201842
+2K131969Symbotex (TM) Composite MeshSofradim Production201310—
+2K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.20089—
+2K052482Artelon Surgical SutureArtimplant AB20050—
+3K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.20230—
+3K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.20230—
+3K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production20223—
+3K173747RexleneSm Eng Co., Ltd.20181—
+3K161633Rexlon, RexsilSm Eng Co., Ltd.20174—
+3K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production201451
+3K130997NeoveilGunze Limited20133—
+4K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc.20240—
+4K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production20242—
+4K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.20240—
+4K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+4K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures20220—
+4K180701SafePath Suturing SystemSafepath Medical, Inc.20181—
+4K150091Versatex Monofilament MeshSofradim Production201542
+4K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+5K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production20251—
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+6K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production20260—