510(k) Report

Devices descending from K000185

26 later devices reach Gore-Tex Dualmesh Plus Biomaterial (1 MM & 2MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+1K032168Gore-Tex Dualmesh Emerge Plus BiomaterialW. L. Gore & Associates, Inc.20030—
+2K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+2K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+2K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+3K211132ARISTE AB MeshAriste Medical, LLC20220—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+3K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+4K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+4K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+4K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+5K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+5K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+6K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+7K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+7K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.20200—