510(k) Report

Devices descending from K012628

18 later devices reach Gynecare Tension-Free Vaginal Tape System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™…ETHICON, Inc.20200—
+1K173162GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE…ETHICON, Inc.20181—
+1K050516T-SlingHerniamesh S.R.L.200613—
+1K051533I-STOPCl Medical20051—
+2K072456Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc.200810—
+2K063713Ams Smart Sling SystemAmerican Medical Systems, Inc.20071—
+2K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+3K103022KIMNeomedic International S.L.20110—
+3K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—
+3K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc.20105—
+3K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.200932
+3K070846Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemProsurg, Inc.20070—
+4K103418Desara MiniCaldera Medical, Inc.20110—
+4K112609Desara MeshCaldera Medical, Inc.20113—
+4K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+5K132069Desara Mesh, Desara BlueCaldera Medical, Inc.20131—
+5K121928Desara SLCaldera Medical, Inc.20130—
+6K140843Desara Blue OV, Desara Blue SSCaldera Medical20140—