510(k) Report

Devices descending from K010533

94 later devices reach Biosling - Bioabsorbable Polymer Sling & Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070846Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemProsurg, Inc.20070—
+1K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.200536—
+1K020652Herniamesh T-SlingHerniamesh200219—
+1K020110Modification to Trelex Mesh Surgical MeshBoston Scientific200238—
+1K020007Safyre Sling SystemPromedon20027—
+2K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20211—
+2K200918SurgiWrap FROSTMast Biosurgery20210—
+2K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation20170—
+2K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+2K121754Blue Sui SlingBoston Scientific Corp20123—
+2K092233Surgimesh XDAspide Medical20100—
+2K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+2K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+2K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081—
+2K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082—
+2K070894Tephaflex Surgical MeshTepha, Inc.200717—
+2K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.2006131
+2K050516T-SlingHerniamesh S.R.L.200613—
+2K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2004271
+2K040787Modification to Surgical Mesh PolymericBoston Scientific20044—
+2K033691Safyre VS and Safyre TPromedon20030—
+2K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034—
+3K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation20230—
+3K143380Phasix ST MeshC.R. Bard, Inc.20154—
+3K142818Phasix MeshC. R. Bard20153—
+3K140533Galaflex MeshTepha, Inc.20143—
+3K120728Phasix Plug and PatchC.R. Bard, Inc.20120—
+3K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+3K112567Biomerix AssureBiomerix Corporation20110—
+3K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+3K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S201001
+3K093799Tornier Surgical MeshTornier, Inc.20102—
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—
+3K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913—
+3K072456Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc.200810—
+3K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+3K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+3K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+3K063713Ams Smart Sling SystemAmerican Medical Systems, Inc.20071—
+3K060018Trulene MeshSutures India Pvt., Ltd.20060—
+3K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.2006161
+4K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+4K202425SurgiLattice scaffoldTepha, Inc.20210—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K162922GalaFORM 3DTepha, Inc.20170—
+4K161424Phasix MeshC.R. Bard, Inc.20162—
+4K161092GalaSHAPE 3DTepha, Inc.201611
+4K113205Artisyn Y-Shaped MeshETHICON, Inc.20120—
+4K112322Restorelle Polypropylene Y MeshColoplast A/S20126—
+4K103022KIMNeomedic International S.L.20110—
+4K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114—
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—
+4K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc.20105—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+4K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.200932
+4K081327RelimeshHerniamesh S.R.L.20080—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB20201—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+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—
+5K103418Desara MiniCaldera Medical, Inc.20110—
+5K112609Desara MeshCaldera Medical, Inc.20113—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+5K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+6K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production20240—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+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—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+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—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—