FDA 510(k) Applications for Medical Device Product Code "FTM"
(Mesh, Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K040621 | ACELL, INC | ACELL UBM SURGICAL MESH | 04/14/2004 |
| K041140 | ACELL, INC | ACELL UBM SURGICAL MESH ML AND MLPLUS | 07/07/2004 |
| K141084 | ACELL, INC | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | 06/17/2015 |
| K162554 | Acell, Inc. | Gentrix Surgical Matrix | 10/21/2016 |
| K170763 | ACell, Inc. | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | 06/08/2017 |
| K182259 | ACell, Inc. | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | 02/07/2019 |
| K203600 | Alafair Biosciences Inc | VersaWrap | 03/09/2021 |
| K213163 | Alafair Biosciences Inc | VersaWrap | 10/29/2021 |
| K200311 | Alafair Biosciences Inc | VersaWrap Tendon Protector | 03/06/2020 |
| K073219 | AMERICAN MEDICAL SYSTEMS, INC. | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 | 04/10/2008 |
| K162461 | AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) | Endoform Plastics and Reconstructive Matrix | 12/20/2016 |
| K153633 | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | Endoform Reconstructive Template | 03/15/2016 |
| K250598 | Aroa Biosurgery Ltd. | Endoform Reconstructive Template - PLGA | 06/03/2025 |
| K183398 | Aroa Biosurgery Ltd. | Endoform Restella | 04/11/2019 |
| K173242 | Aziyo Biologics, Inc. | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) | 10/25/2017 |
| K201313 | Aziyo Biologics, Inc. | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) | 06/15/2020 |
| K192616 | Aziyo Biologics, Inc. | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) | 10/21/2019 |
| K182255 | Aziyo Biologics, Inc. | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) | 11/15/2018 |
| K192452 | B. Bruan Surgical, SA | Lyograft | 09/03/2020 |
| K961811 | BIO-VASCULAR, INC. | PERI-GUARD PERICARDIUM | 06/13/1996 |
| K983162 | BIO-VASCULAR, INC. | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | 10/09/1998 |
| K971048 | BIO-VASCULAR, INC. | PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT | 05/09/1997 |
| K992537 | BIO-VASCULAR, INC. | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | 02/22/2000 |
| K961810 | BIO-VASCULAR, INC. | SUPPLE PERI-GUARD PERICARDIUM | 06/13/1996 |
| K062558 | BIOMET MANUFACTURING CORP. | MESOSFOL SURGICAL FILM | 06/20/2007 |
| K111436 | BRENNEN MEDICAL, LLC | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX | 10/14/2011 |
| K081272 | BRENNEN MEDICAL, LLC | PORCINE SURGICAL MESH; DERMAL MATRIX | 07/31/2008 |
| K140501 | C.R. BARD | XENMATRIX SURGICAL GRAFT | 04/28/2014 |
| K052322 | C.R. BARD, INC. | BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 | 04/10/2006 |
| K063178 | C.R. BARD, INC. | BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 | 11/21/2006 |
| K031332 | C.R. BARD, INC. | BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH | 05/15/2003 |
| K082687 | C.R. BARD, INC. | COLLAMEND FM IMPLANT | 10/17/2008 |
| K021160 | CARBON MEDICAL TECHNOLOGIES, INC. | DERMMATRIX SURGICAL MESH | 06/12/2002 |
| K141721 | COLLAFIRM LLC | BOVINE PERICARDIUM PATCH | 12/22/2014 |
| K080452 | COLLAGEN MATRIX, INC. | COLLAGEN TENDON WRAP | 05/15/2008 |
| K160181 | Colorado Therapeutics LLC | COLORADO THERAPEUTICS XENOGRAFT IMPLANT | 10/20/2016 |
| K172937 | Colorado Therapeutics LLC | Colorado Therapeutics Xenograft Implant | 10/25/2017 |
| K171817 | Cook Biotech Incorporated | Biodesign Diaphragmatic Hernia Graft | 03/13/2018 |
| K170016 | Cook Biotech Incorporated | Biodesign Fistula Plug | 06/21/2017 |
| K162934 | Cook Biotech Incorporated | Biodesign Parastomal Hernia Repair Graft | 07/10/2017 |
| K161221 | Cook Biotech Incorporated | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | 05/26/2016 |
| K201000 | Cook Biotech Incorporated | Biodesign Staple Line Reinforcement | 07/13/2020 |
| K160869 | COOK BIOTECH INCORPORATED | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | 04/29/2016 |
| K150668 | COOK BIOTECH INCORPRATED | Biodesign Enterocutaneous Fistula Plug | 12/09/2015 |
| K142887 | COOK BIOTECH INCORPRATED | SIS Inguinal Hernia Repair Graft | 10/01/2015 |
| K110402 | COOK BIOTECH, INC. | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | 06/20/2011 |
| K070405 | COOK BIOTECH, INC. | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | 10/17/2007 |
| K050246 | COOK BIOTECH, INC. | SIS DERMAL AUGMENTATION STRAND | 05/19/2005 |
| K070738 | COOK BIOTECH, INC. | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT | 04/05/2007 |
| K050337 | COOK BIOTECH, INC. | SIS FISTULA PLUG | 03/09/2005 |
| K133306 | COOK BIOTECH, INC. | SIS HERNIA GRAFT | 07/23/2014 |
| K034039 | COOK BIOTECH, INC. | SIS PLASTIC SURGERY MATRIX | 02/18/2004 |
| K980431 | COOK BIOTECH, INC. | SURGISIS | 05/28/1998 |
| K082682 | COOK BIOTECH, INC. | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | 02/27/2009 |
| K073391 | COOK BIOTECH, INC. | SURGISIS BIODESIGN TISSUE GRAFT | 03/21/2008 |
| K062320 | COOK BIOTECH, INC. | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 | 10/02/2006 |
| K062729 | COOK BIOTECH, INC. | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG | 10/10/2006 |
| K051048 | COOK BIOTECH, INC. | SURGISIS STAPLE LINE REINFORCEMENT II | 09/23/2005 |
| K062696 | COOK BIOTECH, INC. | SURGISIS, SURGISIS ES | 10/13/2006 |
| K140306 | CORMATRIX CARDIOVASCULAR, INC. | CORMATRIX PROTECT ECM ENVELOPE | 08/15/2014 |
| K120605 | Covidien LLC | PERMACOL SURGICAL IMPLANT | 05/18/2012 |
| K061892 | CRYOLIFE, INC. | PROPATCH SOFT TISSUE REPAIR MATRIX | 11/22/2006 |
| K101587 | CRYOLIFE, INC. | PROPATCH SOFT TISSUE REPAIR MATRIX | 09/16/2010 |
| K110581 | CRYOLIFE, INC. | PROPATCH SOFT TISSUE REPAIR MATRIX | 01/10/2012 |
| K162388 | CURASEAL, INC. | CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) | 02/03/2017 |
| K031969 | DEPUY ORTHOPAEDICS, INC. | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | 07/28/2003 |
| K071016 | DEPUY ORTHOPAEDICS, INC. | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | 09/04/2007 |
| K001738 | DEPUY ORTHOPAEDICS, INC. | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | 12/27/2000 |
| K982330 | DEPUY, INC. | DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | 09/25/1998 |
| K233991 | Elutia Inc. | CanGaroo RM Antibacterial Envelope | 06/14/2024 |
| K203496 | Geistlich Pharma AG | Nexo-Gide Bilayer Collagen Membrane | 07/14/2021 |
| K040868 | GENZYME CORP. | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH | 06/04/2004 |
| K963175 | GLYCAR, INC. | GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING | 09/23/1996 |
| K040756 | IMPLEX CORP. | THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX | 07/14/2004 |
| K053655 | INTEGRA LIFESCIENCES CORPORATION | TENDON WRAP TENDON PROTECTOR | 02/03/2006 |
| K041923 | KENSEY NASH CORP. | BIOBLANKET | 09/08/2004 |
| K043259 | KENSEY NASH CORP. | BIOBLANKET SURGICAL MESH | 08/15/2005 |
| K103787 | KENSEY NASH CORP. | MEDEOR MATRIX | 02/07/2011 |
| K091499 | KENSEY NASH CORP. | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | 10/22/2009 |
| K061030 | KENSEY NASH CORPORATION | BIOBLANKET SURGICAL MESH | 05/09/2006 |
| K094061 | KENSEY NASH CORPORATION | KENSEY NASH ECM SURGICAL PATCH | 05/18/2010 |
| K132025 | KENSEY NASH CORPORATION DBA DSM BIOMEDICAL | MESO BILAYER SURGICAL MESH | 10/30/2013 |
| K070560 | LIFECELL CORP. | LRTM SURGICAL MESH | 06/11/2007 |
| K082176 | LIFECELL CORP. | LTM-BPS SURGICAL MESH | 11/14/2008 |
| K071986 | LIFECELL CORP. | LTM-RC SURGICAL MESH | 10/19/2007 |
| K162752 | LIFECELL CORPORATION | ARTIA Reconstructive Tissue Matrix Perforated | 02/24/2017 |
| K142326 | LifeCell Corporation | HP Tissue Matrix | 12/23/2014 |
| K150712 | LifeCell Corporation | LTM-Perforated Surgical Mesh | 07/02/2015 |
| K130547 | MESYNTHE LTD | ENDOFORM RECONSTRUCTIVE TEMPLATE | 05/31/2013 |
| K134033 | MIROMATRIX MEDICAL INC. | MIROMATRIX BIOLOGICAL MESH | 03/31/2014 |
| K162570 | Miromatrix Medical Inc. | Miromatrix Biological Mesh TW | 02/16/2017 |
| K042809 | ORGANOGENESIS, INC. | CUFFPATCH | 11/02/2004 |
| K011025 | ORGANOGENESIS, INC. | FORTAFLEX SURGICAL MESH | 08/24/2001 |
| K020049 | ORGANOGENESIS, INC. | FORTAFLEX SURGICAL MESH | 03/18/2002 |
| K021105 | ORGANOGENESIS, INC. | FORTAFLEX SURGICAL MESH | 05/10/2002 |
| K011027 | ORGANOGENESIS, INC. | FORTAFLEX SURGICAL SLING | 05/30/2001 |
| K021107 | ORGANOGENESIS, INC. | FORTAFLEX SURGICAL SLING | 05/15/2002 |
| K071065 | PEGASUS BIOLOGICS, INC. | ORTHADAPT BIOIMPLANT | 05/04/2007 |
| K043388 | PEGASUS BIOLOGICS, INC. | PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH | 08/05/2005 |
| K063556 | PM DEVICES, INC. | PERIPATCH ENDO-SLEEVE | 03/20/2007 |
| K040835 | PM DEVICES, INC. | PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 | 06/15/2004 |
| K033985 | PM DEVICES, INC. | PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 | 06/04/2004 |
| K040364 | POREX SURGICAL, INC. | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | 06/30/2004 |
| K112423 | ROTATION MEDICAL, INC. | COLLAGEN TENDON SHEET | 12/22/2011 |
| K122048 | ROTATION MEDICAL, INC. | COLLAGEN TENDON SHEET-D | 01/08/2013 |
| K123356 | RTI BIOLOGICS, INC. | FORTIVA PORCINE DERMIS | 03/05/2013 |
| K081538 | RTI BIOLOGICS, INC. | TUTOPATCH, TUTOMESH | 06/19/2008 |
| K091142 | RTI BIOLOGICS, INC. | TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 | 08/31/2009 |
| K142070 | RTI SURGICAL, INC. | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | 10/27/2014 |
| K973379 | S. JACKSON, INC. | STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS | 09/25/1997 |
| K991567 | SHELHIGH, INC. | SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. | 07/14/1999 |
| K223052 | Synovis Life Technologies, Inc. | Peri-Guard and Supple Peri-Guard | 04/07/2023 |
| K192615 | Synovis Life Technologies, Inc. (Baxter International Inc.) | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | 12/17/2019 |
| K213125 | Synovis Life Technologies. Inc. (A Subsidiary Of Baxter | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | 10/27/2021 |
| K113460 | SYNOVIS ORTHOPEDIC & WOUNDCARE | SYNERGY TISSUE MATRIX | 01/11/2012 |
| K112786 | SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. | PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF | 10/25/2011 |
| K040119 | SYNOVIS SURGICAL INNOVATIONS | PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION | 03/17/2004 |
| K062915 | SYNOVIS SURGICAL INNOVATIONS | VERITAS COLLAGEN MATRIX | 12/06/2006 |
| K083039 | SYNOVIS SURGICAL INNOVATIONS | VERITAS COLLAGEN MATRIX (DRY) | 11/26/2008 |
| K041669 | SYNOVIS SURGICAL INNOVATIONS | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | 10/27/2004 |
| K051879 | SYNTHES (USA) | SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS | 10/05/2005 |
| K183472 | Synthes (USA) Products LLC | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio û MR Conditional | 03/13/2019 |
| K060829 | TEI BIOSCIENCES INC. | COSMATRIX | 05/17/2006 |
| K071807 | TEI BIOSCIENCES INC. | ORTHOMEND SOFT TISSUE MATRIX | 08/06/2007 |
| K083898 | TEI BIOSCIENCES INC. | SURGIMEND | 02/04/2009 |
| K162965 | TEI Biosciences Inc. | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | 02/16/2017 |
| K020455 | TEI BIOSCIENCES INC. | TISSUEMEND SOFT TISSUE REPAIR MATRIX | 04/03/2002 |
| K060989 | TEI BIOSCIENCES INC. | TISSUEMEND SOFT TISSUE REPAIR MATRIX | 05/15/2006 |
| K060984 | TEI BIOSCIENCES INC. | XENFORM SOFT TISSUE REPAIR MATRIX | 05/17/2006 |
| K214070 | TELA Bio | OviTex PRS (Long Term Resorbable) | 03/21/2023 |
| K141053 | TELA BIO, INC. | OVINE TISSUE MATRIX(OTM) | 12/11/2014 |
| K241126 | Tela Bio, Inc. | OviTex PRS | 05/22/2024 |
| K243595 | TELA Bio, Inc. | OviTex PRS (Long-Term Resorbable) | 12/19/2024 |
| K182493 | Tisgenx | Bovine Pericardial Tissue Patch | 06/18/2019 |
| K152206 | TISSUE REGENIX GROUP PLC | SurgiPure XD Reconstructive Tissue Matrix | 03/08/2016 |
| K013625 | TISSUE SCIENCE LABORATORIES, PLC | PERMACOL | 01/17/2002 |
| K021056 | TISSUE SCIENCE LABORATORIES, PLC | PERMACOL | 10/31/2002 |
| K053562 | TISSUE SCIENCE LABORATORIES, PLC | ZIMMER COLLAGEN REPAIR PATCH | 06/23/2006 |
| K991296 | TUTOGEN MEDICAL U.S., INC. | TUTOPATCH | 10/06/2000 |
| K030782 | W. L. GORE & ASSOCIATES, INC. | SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | 04/21/2003 |
| K120019 | WRIGHT MEDICAL TECHNOLOGY, INC. | COLLAGEN RIBBON | 02/23/2012 |
| K081882 | XYLOS CORPORATION | MODIFICATION TO XYLOS SURGICAL MESH | 07/11/2008 |
| K090778 | XYLOS CORPORATION | MTA PROTECTIVE SHEET | 04/28/2009 |
| K083823 | XYLOS CORPORATION | SECURIAN TISSUE REINFORCEMENT MATRIX | 03/18/2009 |
| K111584 | XYLOS CORPORATION | XYLOS MACRO-POROUS SURGICAL MESH | 08/25/2011 |
| K090880 | XYLOS CORPORATION | XYLOS POROUS SURGICAL MESH | 05/27/2009 |
| K023237 | XYLOS CORPORATION | XYLOS SURGICAL MESH | 03/18/2003 |
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