510(k) Report

Devices descending from K963226

280 later devices reach Surgical Fabrics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+7K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+7K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+7K241080Kerecis Parvus (50207)Kerecis Limited20241—
+7K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+7K213231Kerecis SiliconeKerecis Limited20221—
+7K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+7K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+7K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+7K180776Cytal Wound ParticulateAcell, Inc.20180—
+7K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+7K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+7K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+7K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+7K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+7K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+7K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+7K123128Seri Surgical ScaffoldAllergan20135—
+7K123914Restorelle Y ContourColoplast A/S20132—
+7K122794Upsylon Y MeshBoston Scientific Corp20120—
+7K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+7K121805Ams Large Pore Polyprophlene MeshAmerican Medical Systems20120—
+7K083722AscendCaldera Medical, Inc.20097—
+7K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.200820—
+7K080836Modification to Endofast Reliant SystemEndogun Medical Systems20081—
+7K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+7K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K260218LacertaMatrixLacerta Life Sciences20260—
+8K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+8K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+8K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+8K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+8K172545SERI ContourSofregen Medical, Inc.20170—
+8K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+8K140533Galaflex MeshTepha, Inc.20143—
+8K140116Restorelle Y Contour MeshColoplast A/S20141—
+8K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+8K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd.20130—
+8K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc.20106—
+8K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S20091—
+8K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+8K082216TBD Ethicon MeshETHICON, Inc.20081—
+8K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp200861
+8K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+9K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+9K202425SurgiLattice scaffoldTepha, Inc.20210—
+9K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+9K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+9K173527Digitex Delivery DeviceColoplast A/S20180—
+9K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+9K162922GalaFORM 3DTepha, Inc.20170—
+9K161092GalaSHAPE 3DTepha, Inc.201611
+9K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+9K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+9K120327VertessaCaldera Medical, Inc.20125—
+9K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+9K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+9K091131Pelvic Floor Repair SystemBoston Scientific20095—
+9K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+10K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+10K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+10K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+10K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+10K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+10K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+10K122440Restorelle LColoplast Corp.201211
+10K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+10K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+11K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+11K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+11K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+11K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.20200—
+11K150016Vertessa LiteCaldera Medical, Inc.20150—
+11K132061Restorelle M, Restorelle XLColoplast Corp.20130—