510(k) Report

Devices descending from K002721

113 later devices reach Ams Triangle Silicone-Coated Sling and Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+8K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+8K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—
+8K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+8K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+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—
+8K150016Vertessa LiteCaldera Medical, Inc.20150—
+8K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+9K260317Artelon Convenience KitsInternational Life Sciences20260—
+9K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+9K242187BioBrace®Conmed Corporation20241—
+10K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—