FDA Product Code
FDA Product Code FTM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 164 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262406 | EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific | 2026-08-12 | Special | PDF ↗ |
| K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. | 2025-06-03 | Traditional | PDF ↗ |
| K243595 | OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. | 2024-12-19 | Special | PDF ↗ |
| K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | 2024-06-14 | Traditional | PDF ↗ |
| K241126 | OviTex PRS | TELA Bio, Inc. | 2024-05-22 | Special | PDF ↗ |
| K223052 | Peri-Guard and Supple Peri-Guard | Synovis Life Technologies, Inc. | 2023-04-07 | Traditional | PDF ↗ |
| K214070 | OviTex PRS (Long Term Resorbable) | Tela Bio | 2023-03-21 | Traditional | PDF ↗ |
| K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021-10-29 | Special | PDF ↗ |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021-10-27 | Special | PDF ↗ |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | Geistlich Pharma AG | 2021-07-14 | Traditional | PDF ↗ |
| K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021-03-09 | Traditional | PDF ↗ |
| K192452 | Lyograft | B. Bruan Surgical, SA | 2020-09-03 | Traditional | PDF ↗ |
| K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2020-07-13 | Traditional | PDF ↗ |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) | Aziyo Biologics, Inc. | 2020-06-15 | Special | PDF ↗ |
| K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020-03-06 | Special | PDF ↗ |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019-12-17 | Traditional | PDF ↗ |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) | Aziyo Biologics, Inc. | 2019-10-21 | Special | PDF ↗ |
| K182493 | Bovine Pericardial Tissue Patch | Tisgenx | 2019-06-18 | Traditional | PDF ↗ |
| K183398 | Endoform Restella | Aroa Biosurgery , Ltd. | 2019-04-11 | Traditional | PDF ↗ |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional | Synthes (USA) Products, LLC | 2019-03-13 | Traditional | PDF ↗ |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Acell, Inc. | 2019-02-07 | Traditional | PDF ↗ |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) | Aziyo Biologics, Inc. | 2018-11-15 | Traditional | PDF ↗ |
| K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | 2018-03-13 | Traditional | PDF ↗ |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) | Aziyo Biologics, Inc. | 2017-10-25 | Special | PDF ↗ |
| K172937 | Colorado Therapeutics Xenograft Implant | Colorado Therapeutics, LLC | 2017-10-25 | Special | PDF ↗ |
| K162934 | Biodesign Parastomal Hernia Repair Graft | Cook Biotech Incorporated | 2017-07-10 | Traditional | PDF ↗ |
| K170016 | Biodesign Fistula Plug | Cook Biotech Incorporated | 2017-06-21 | Traditional | PDF ↗ |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | Acell, Inc. | 2017-06-08 | Traditional | PDF ↗ |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | Lifecell Corporation | 2017-02-24 | Traditional | PDF ↗ |
| K162570 | Miromatrix Biological Mesh TW | Miromatrix Medical, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | Tei Biosciences, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K162388 | CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) | Curaseal, Inc. | 2017-02-03 | Traditional | PDF ↗ |
| K162461 | Endoform Plastics and Reconstructive Matrix | Aroa Biosurgery (Formerly Mesynthes Limited) | 2016-12-20 | Traditional | PDF ↗ |
| K162554 | Gentrix Surgical Matrix | Acell, Inc. | 2016-10-21 | Special | PDF ↗ |
| K160181 | COLORADO THERAPEUTICS XENOGRAFT IMPLANT | Colorado Therapeutics, LLC | 2016-10-20 | Traditional | PDF ↗ |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016-05-26 | Special | PDF ↗ |
| K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | Cook Biotech Incorporated | 2016-04-29 | Special | PDF ↗ |
| K153633 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016-03-15 | Special | PDF ↗ |
| K152206 | SurgiPure XD Reconstructive Tissue Matrix | Tissue Regenix Group Plc | 2016-03-08 | Traditional | PDF ↗ |
| K150668 | Biodesign Enterocutaneous Fistula Plug | Cook Biotech Incorprated | 2015-12-09 | Traditional | PDF ↗ |
| K142887 | SIS Inguinal Hernia Repair Graft | Cook Biotech Incorprated | 2015-10-01 | Traditional | PDF ↗ |
| K150712 | LTM-Perforated Surgical Mesh | Lifecell Corporation | 2015-07-02 | Traditional | PDF ↗ |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | Acell, Inc. | 2015-06-17 | Traditional | PDF ↗ |
| K142326 | HP Tissue Matrix | Lifecell Corporation | 2014-12-23 | Traditional | PDF ↗ |
| K141721 | BOVINE PERICARDIUM PATCH | Collafirm, LLC | 2014-12-22 | Traditional | PDF ↗ |
| K141053 | OVINE TISSUE MATRIX(OTM) | TELA Bio, Inc. | 2014-12-11 | Traditional | PDF ↗ |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | Rti Surgical, Inc. | 2014-10-27 | Abbreviated | PDF ↗ |
| K140306 | CORMATRIX PROTECT ECM ENVELOPE | Cormatrix Cardiovascular, Inc. | 2014-08-15 | Traditional | PDF ↗ |
| K133306 | SIS HERNIA GRAFT | Cook Biotech, Inc. | 2014-07-23 | Traditional | PDF ↗ |
| K140501 | XENMATRIX SURGICAL GRAFT | C. R. Bard | 2014-04-28 | Special | PDF ↗ |
| K134033 | MIROMATRIX BIOLOGICAL MESH | Miromatrix Medical, Inc. | 2014-03-31 | Traditional | PDF ↗ |
| K132025 | MESO BILAYER SURGICAL MESH | Kensey Nash Corporation Dba Dsm Biomedical | 2013-10-30 | Traditional | PDF ↗ |
| K130547 | ENDOFORM RECONSTRUCTIVE TEMPLATE | Mesynthe, Ltd. | 2013-05-31 | Traditional | PDF ↗ |
| K123356 | FORTIVA PORCINE DERMIS | Rti Biologics, Inc. | 2013-03-05 | Traditional | PDF ↗ |
| K122048 | COLLAGEN TENDON SHEET-D | Rotation Medical, Inc. | 2013-01-08 | Traditional | PDF ↗ |
| K120605 | PERMACOL SURGICAL IMPLANT | Covidien, LLC | 2012-05-18 | Traditional | PDF ↗ |
| K120019 | COLLAGEN RIBBON | Wrightmedicaltechnologyinc | 2012-02-23 | Traditional | PDF ↗ |
| K113460 | SYNERGY TISSUE MATRIX | Synovis Orthopedic & Woundcare | 2012-01-11 | Traditional | PDF ↗ |
| K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX | Cryolife, Inc. | 2012-01-10 | Traditional | PDF ↗ |
| K112423 | COLLAGEN TENDON SHEET | Rotation Medical, Inc. | 2011-12-22 | Traditional | PDF ↗ |
| K112786 | PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF | Synovis Orthopedic and Woundcare, Inc. | 2011-10-25 | Special | PDF ↗ |
| K111436 | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX | Brennen Medical, LLC | 2011-10-14 | Traditional | PDF ↗ |
| K111584 | XYLOS MACRO-POROUS SURGICAL MESH | Xylos Corporation | 2011-08-25 | Traditional | PDF ↗ |
| K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | Cook Biotech, Inc. | 2011-06-20 | Traditional | PDF ↗ |
| K103787 | MEDEOR MATRIX | Kensey Nash Corp. | 2011-02-07 | Traditional | PDF ↗ |
| K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX | Cryolife, Inc. | 2010-09-16 | Traditional | PDF ↗ |
| K094061 | KENSEY NASH ECM SURGICAL PATCH | Kensey Nash Corporation | 2010-05-18 | Traditional | PDF ↗ |
| K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | Kensey Nash Corp. | 2009-10-22 | Traditional | PDF ↗ |
| K091142 | TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 | Rti Biologics, Inc. | 2009-08-31 | Special | PDF ↗ |
| K090880 | XYLOS POROUS SURGICAL MESH | Xylos Corporation | 2009-05-27 | Special | PDF ↗ |
| K090778 | MTA PROTECTIVE SHEET | Xylos Corporation | 2009-04-28 | Traditional | PDF ↗ |
| K083823 | SECURIAN TISSUE REINFORCEMENT MATRIX | Xylos Corporation | 2009-03-18 | Traditional | PDF ↗ |
| K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | Cook Biotech, Inc. | 2009-02-27 | Traditional | PDF ↗ |
| K083898 | SURGIMEND | Tei Biosciences, Inc. | 2009-02-04 | Special | PDF ↗ |
| K083039 | VERITAS COLLAGEN MATRIX (DRY) | Synovis Surgical Innovations | 2008-11-26 | Traditional | PDF ↗ |
| K082176 | LTM-BPS SURGICAL MESH | Lifecell Corp. | 2008-11-14 | Traditional | PDF ↗ |
| K082687 | COLLAMEND FM IMPLANT | C.R. Bard, Inc. | 2008-10-17 | Traditional | PDF ↗ |
| K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX | Brennen Medical, LLC | 2008-07-31 | Traditional | PDF ↗ |
| K081882 | MODIFICATION TO XYLOS SURGICAL MESH | Xylos Corporation | 2008-07-11 | Special | PDF ↗ |
| K081538 | TUTOPATCH, TUTOMESH | Rti Biologics, Inc. | 2008-06-19 | Special | PDF ↗ |
| K080452 | COLLAGEN TENDON WRAP | Collagen Matrix, Inc. | 2008-05-15 | Traditional | PDF ↗ |
| K073219 | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 | American Medical Systems, Inc. | 2008-04-10 | Traditional | PDF ↗ |
| K073391 | SURGISIS BIODESIGN TISSUE GRAFT | Cook Biotech, Inc. | 2008-03-21 | Traditional | PDF ↗ |
| K071986 | LTM-RC SURGICAL MESH | Lifecell Corp. | 2007-10-19 | Traditional | PDF ↗ |
| K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | Cook Biotech, Inc. | 2007-10-17 | Traditional | PDF ↗ |
| K071016 | DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT | DePuy Orthopaedics, Inc. | 2007-09-04 | Traditional | PDF ↗ |
| K071807 | ORTHOMEND SOFT TISSUE MATRIX | Tei Biosciences, Inc. | 2007-08-06 | Special | PDF ↗ |
| K062558 | MESOSFOL SURGICAL FILM | Biomet Manufacturing Corp | 2007-06-20 | Traditional | PDF ↗ |
| K070560 | LRTM SURGICAL MESH | Lifecell Corp. | 2007-06-11 | Traditional | PDF ↗ |
| K071065 | ORTHADAPT BIOIMPLANT | Pegasus Biologics, Inc. | 2007-05-04 | Special | PDF ↗ |
| K070738 | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT | Cook Biotech, Inc. | 2007-04-05 | Special | PDF ↗ |
| K063556 | PERIPATCH ENDO-SLEEVE | Pm Devices, Inc. | 2007-03-20 | Traditional | PDF ↗ |
| K062915 | VERITAS COLLAGEN MATRIX | Synovis Surgical Innovations | 2006-12-06 | Traditional | PDF ↗ |
| K061892 | PROPATCH SOFT TISSUE REPAIR MATRIX | Cryolife, Inc. | 2006-11-22 | Abbreviated | PDF ↗ |
| K063178 | BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 | C.R. Bard, Inc. | 2006-11-21 | Traditional | PDF ↗ |
| K062696 | SURGISIS, SURGISIS ES | Cook Biotech, Inc. | 2006-10-13 | Special | PDF ↗ |
| K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG | Cook Biotech, Inc. | 2006-10-10 | Special | PDF ↗ |
| K062320 | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 | Cook Biotech, Inc. | 2006-10-02 | Traditional | PDF ↗ |
| K053562 | ZIMMER COLLAGEN REPAIR PATCH | Tissue Science Laboratories, Plc | 2006-06-23 | Traditional | PDF ↗ |
| K060984 | XENFORM SOFT TISSUE REPAIR MATRIX | Tei Biosciences, Inc. | 2006-05-17 | Special | PDF ↗ |
Product code FTM · Class II · General, Plastic Surgery. Data: openFDA.