510(k) Report

Devices descending from K922916

133 later devices reach Bard Marlex Mesh Dart through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+7K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+7K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+7K120327VertessaCaldera Medical, Inc.20125—
+7K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+7K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp.20110—
+7K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+7K091131Pelvic Floor Repair SystemBoston Scientific20095—
+7K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+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—
+8K151083BioBridge Collagen MatrixFibralign Corporation20169—
+8K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+8K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical20131—
+8K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp.20120—
+8K122440Restorelle LColoplast Corp.201211
+8K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+8K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+9K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+9K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+9K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+9K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+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—
+9K150016Vertessa LiteCaldera Medical, Inc.20150—
+9K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+10K260317Artelon Convenience KitsInternational Life Sciences20260—
+10K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+10K242187BioBrace®Conmed Corporation20241—
+11K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—