510(k) Report

Devices descending from K002093

33 later devices reach Atrium Lite Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151437ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugAtrium Medical Corporation201501
+1K142192Insightra Freedom Ventral Hernia Repair SystemInsightra Medical20150—
+1K073579Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNNFeg Textiltechnik Forschungs-Und Entwicklungsgesel20083—
+1K043081Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc.200426—
+2K131530Dynamesh -CicatFeg Textiltechnik Forschungs-Und Entwicklungsgesel20132—
+2K052864Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc.200525—
+3K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20161—
+3K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624—
+4K182087DynaMesh-POSTERIORFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft20180—
+4K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.2008173
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+5K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+5K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+6K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+6K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+6K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+6K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+6K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+6K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+7K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+7K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+7K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+7K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+8K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+8K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+8K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+9K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+9K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+9K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.20200—