510(k) Report

Devices descending from K021263

109 later devices reach Modification to Sparc Sling System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+7K150016Vertessa LiteCaldera Medical, Inc.20150—
+7K140116Restorelle Y Contour MeshColoplast A/S20141—
+7K132061Restorelle M, Restorelle XLColoplast Corp.20130—
+7K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+7K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K173527Digitex Delivery DeviceColoplast A/S20180—
+8K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—