510(k) Report

Devices descending from K072028

26 later devices reach Quill Self-Retaining System (SRS) Comprised of Monoderm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+1K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+1K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201218—
+1K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012191
+1K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+2K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+2K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.201581
+2K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation201410—
+2K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+2K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+3K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+3K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.20220—
+3K202950StitchKit COMBOOrigami Surgical20212—
+3K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+3K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+3K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+4K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+4K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+4K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+4K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—
+4K233355Cypris eXact Suturing SystemCypris Medical20240—
+4K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+4K211178DURAMESH Mesh SutureMsi20220—
+4K211792StitchKitOrigami Surgical Inc .20211—
+4K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+5K221527StitchKitOrigami Surgical Inc .20230—