510(k) Report

Devices descending from K002672

35 later devices reach Vypro Mesh, Vicryl Prolene Partially Absorbable Synthetic Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053424PopmeshCaldera Medical, Inc.20068—
+1K052864Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc.200525—
+2K120327VertessaCaldera Medical, Inc.20125—
+2K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+2K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+3K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+3K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+3K122440Restorelle LColoplast Corp.201211
+3K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+3K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+3K081327RelimeshHerniamesh S.R.L.20080—
+3K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+4K211132ARISTE AB MeshAriste Medical, LLC20220—
+4K150016Vertessa LiteCaldera Medical, Inc.20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+4K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+4K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+5K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+5K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+6K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+6K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+6K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+7K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+8K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+8K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+8K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.20200—