510(k) Report

Devices descending from K974098

83 later devices reach Pubouurethral Sling through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE…ETHICON, Inc.20181—
+1K100485Gynecare TVT Exact Continence SystemETHICON, Inc.20104—
+1K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—
+1K052175I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000Uroplasty, Inc.20051—
+1K041176Uretex to Trans-Obturator Urethral Support SystemSofradim Production20044—
+1K031767Mentor Obtape Trans-Obturator TapeMentor Corp.200315—
+1K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034—
+1K020652Herniamesh T-SlingHerniamesh200219—
+1K020654Stratasis Sling KitCook Biotech, Inc.20020—
+1K020110Modification to Trelex Mesh Surgical MeshBoston Scientific200238—
+1K020007Safyre Sling SystemPromedon20027—
+1K012949Uretex Sup Pubourethral SlingSofradim Production20010—
+2K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20211—
+2K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™…ETHICON, Inc.20200—
+2K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation20170—
+2K132054Gynecare TVT Exact Continence SystemETHICON, Inc.20133—
+2K121754Blue Sui SlingBoston Scientific Corp20123—
+2K103022KIMNeomedic International S.L.20110—
+2K092233Surgimesh XDAspide Medical20100—
+2K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+2K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081—
+2K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082—
+2K070073Align Urethral Support SystemC.R. Bard, Inc.20071—
+2K061445Surgimesh WNAspide Medical200752
+2K050516T-SlingHerniamesh S.R.L.200613—
+2K051533I-STOPCl Medical20051—
+2K050148Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation20057—
+2K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2004271
+2K042851Mentor Obtape Trans-Obturator Surgical KitMentor Corp.20048—
+2K040787Modification to Surgical Mesh PolymericBoston Scientific20044—
+2K033691Safyre VS and Safyre TPromedon20030—
+3K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…Coloplast Corp.20240—
+3K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20230—
+3K210087Athena Surgical RMUS SystemAthena Surgical, LLC20210—
+3K121562Altis Single Incision Cling SystemColoplast A/S20122—
+3K120025Surgimesh XB - SkirtedAspide Medical20120—
+3K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+3K093747Align and Align to Urethral Support SystemsC.R. Bard, Inc.20100—
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+3K072974Surgimesh XBAspide Medical200832
+3K072456Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc.200810—
+3K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+3K063713Ams Smart Sling SystemAmerican Medical Systems, Inc.20071—
+3K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+3K060018Trulene MeshSutures India Pvt., Ltd.20060—
+3K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+3K053296Mentor Aris Suprapubic Surgical KitMentor Corporation20052—
+4K221874Altis Single Incision Sling SystemColoplast A/S20231—
+4K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+4K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+4K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+4K111233Supris Retropubic Sling SystemColoplast A/S20111—
+4K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—
+4K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc.20105—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+4K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.200932
+4K081327RelimeshHerniamesh S.R.L.20080—
+4K070846Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemProsurg, Inc.20070—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc.20131—
+5K123914Restorelle Y ContourColoplast A/S20132—
+5K122794Upsylon Y MeshBoston Scientific Corp20120—
+5K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation201222
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K103418Desara MiniCaldera Medical, Inc.20110—
+5K112609Desara MeshCaldera Medical, Inc.20113—
+5K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+5K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+6K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation201714
+6K150023Vertessa Lite Y-MeshCaldera Medical, Inc.20150—
+6K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+6K140116Restorelle Y Contour MeshColoplast A/S20141—
+6K132069Desara Mesh, Desara BlueCaldera Medical, Inc.20131—
+6K121928Desara SLCaldera Medical, Inc.20130—
+7K173527Digitex Delivery DeviceColoplast A/S20180—
+7K173501Meridian Vaginal Positioning System (VPS)Coloplast20180—
+7K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+7K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+7K140843Desara Blue OV, Desara Blue SSCaldera Medical20140—