510(k) Report

Devices descending from K963611

120 later devices reach Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+10K151083BioBridge Collagen MatrixFibralign Corporation20169—
+10K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+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—
+11K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+11K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+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—
+12K260317Artelon Convenience KitsInternational Life Sciences20260—
+12K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+12K242187BioBrace®Conmed Corporation20241—
+13K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—