510(k) Report

Devices descending from K053656

24 later devices reach Tyrx Antimicrobial Mesh through their predicates, nearest generation first.

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