510(k) Report

Devices descending from K980482

114 later devices reach Triangle Sling through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—