510(k) Report

Devices descending from K011251

123 later devices reach Sparc Sling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222468ArcTO Transobturator Sling SystemUrocure, LLC20220—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation20170—
+6K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+6K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+6K150016Vertessa LiteCaldera Medical, Inc.20150—
+6K140116Restorelle Y Contour MeshColoplast A/S20141—
+6K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+6K112567Biomerix AssureBiomerix Corporation20110—
+6K103022KIMNeomedic International S.L.20110—
+6K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.200932
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K242187BioBrace®Conmed Corporation20241—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K173527Digitex Delivery DeviceColoplast A/S20180—
+7K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+7K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+7K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—