Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent2Product Code
- EZXMesh, Surgical, Metal2Product Code
- MIBElastomer, Silicone Block2Product Code
- MICImplant, Muscle, Pectoralis2Product Code
- BTXBoard, Arm (With Cover), Sterile1Product Code
- FTLMesh, Surgical, Polymeric2Product Code
- FTMMesh, Surgical2Product Code
- K233991CanGaroo RM Antibacterial Envelope2Cleared 510(K)
- K241126OviTex PRS2Cleared 510(K)
- K223052Peri-Guard and Supple Peri-Guard2Cleared 510(K)
- K214070OviTex PRS (Long Term Resorbable)2Cleared 510(K)
- K213163VersaWrap2Cleared 510(K)
- K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology2Cleared 510(K)
- K203496Nexo-Gide Bilayer Collagen Membrane2Cleared 510(K)
- K203600VersaWrap2Cleared 510(K)
- K192452Lyograft2Cleared 510(K)
- K201000Biodesign Staple Line Reinforcement2Cleared 510(K)
- K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)2Cleared 510(K)
- K200311VersaWrap Tendon Protector2Cleared 510(K)
- K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)2Cleared 510(K)
- K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)2Cleared 510(K)
- K182493Bovine Pericardial Tissue Patch2Cleared 510(K)
- K183398Endoform Restella2Cleared 510(K)
- K183472DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional2Cleared 510(K)
- K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal2Cleared 510(K)
- K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)2Cleared 510(K)
- K171817Biodesign Diaphragmatic Hernia Graft2Cleared 510(K)
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)2Cleared 510(K)
- K172937Colorado Therapeutics Xenograft Implant2Cleared 510(K)
- K162934Biodesign Parastomal Hernia Repair Graft2Cleared 510(K)
- K170016Biodesign Fistula Plug2Cleared 510(K)
- K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend2Cleared 510(K)
- K162752ARTIA Reconstructive Tissue Matrix Perforated2Cleared 510(K)
- K162965SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction2Cleared 510(K)
- K162570Miromatrix Biological Mesh TW2Cleared 510(K)
- K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)2Cleared 510(K)
- K162461Endoform Plastics and Reconstructive Matrix2Cleared 510(K)
- K162554Gentrix Surgical Matrix2Cleared 510(K)
- K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANT2Cleared 510(K)
- K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug2Cleared 510(K)
- K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft2Cleared 510(K)
- K153633Endoform Reconstructive Template2Cleared 510(K)
- K152206SurgiPure XD Reconstructive Tissue Matrix2Cleared 510(K)
- K150668Biodesign Enterocutaneous Fistula Plug2Cleared 510(K)
- K142887SIS Inguinal Hernia Repair Graft2Cleared 510(K)
- K150712LTM-Perforated Surgical Mesh2Cleared 510(K)
- K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix2Cleared 510(K)
- K142326HP Tissue Matrix2Cleared 510(K)
- K141721BOVINE PERICARDIUM PATCH2Cleared 510(K)
- K141053OVINE TISSUE MATRIX(OTM)2Cleared 510(K)
- K142070FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS2Cleared 510(K)
- K140306CORMATRIX PROTECT ECM ENVELOPE2Cleared 510(K)
- K133306SIS HERNIA GRAFT2Cleared 510(K)
- K140501XENMATRIX SURGICAL GRAFT2Cleared 510(K)
- K134033MIROMATRIX BIOLOGICAL MESH2Cleared 510(K)
- K132025MESO BILAYER SURGICAL MESH2Cleared 510(K)
- K130547ENDOFORM RECONSTRUCTIVE TEMPLATE2Cleared 510(K)
- K123356FORTIVA PORCINE DERMIS2Cleared 510(K)
- K122048COLLAGEN TENDON SHEET-D2Cleared 510(K)
- K120605PERMACOL SURGICAL IMPLANT2Cleared 510(K)
- K120019COLLAGEN RIBBON2Cleared 510(K)
- K113460SYNERGY TISSUE MATRIX2Cleared 510(K)
- K110581PROPATCH SOFT TISSUE REPAIR MATRIX2Cleared 510(K)
- K112423COLLAGEN TENDON SHEET2Cleared 510(K)
- K112786PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF2Cleared 510(K)
- K111436PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX2Cleared 510(K)
- K111584XYLOS MACRO-POROUS SURGICAL MESH2Cleared 510(K)
- K110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDER2Cleared 510(K)
- K103787MEDEOR MATRIX2Cleared 510(K)
- K101587PROPATCH SOFT TISSUE REPAIR MATRIX2Cleared 510(K)
- K094061KENSEY NASH ECM SURGICAL PATCH2Cleared 510(K)
- K091499MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)2Cleared 510(K)
- K091142TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 683582Cleared 510(K)
- K090880XYLOS POROUS SURGICAL MESH2Cleared 510(K)
- K090778MTA PROTECTIVE SHEET2Cleared 510(K)
- K083823SECURIAN TISSUE REINFORCEMENT MATRIX2Cleared 510(K)
- K082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG2Cleared 510(K)
- K083898SURGIMEND2Cleared 510(K)
- K083039VERITAS COLLAGEN MATRIX (DRY)2Cleared 510(K)
- K082176LTM-BPS SURGICAL MESH2Cleared 510(K)
- K082687COLLAMEND FM IMPLANT2Cleared 510(K)
- K081272PORCINE SURGICAL MESH; DERMAL MATRIX2Cleared 510(K)
- K081882MODIFICATION TO XYLOS SURGICAL MESH2Cleared 510(K)
- K081538TUTOPATCH, TUTOMESH2Cleared 510(K)
- K080452COLLAGEN TENDON WRAP2Cleared 510(K)
- K073219WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X082Cleared 510(K)
- K073391SURGISIS BIODESIGN TISSUE GRAFT2Cleared 510(K)
- K071986LTM-RC SURGICAL MESH2Cleared 510(K)
- K070405MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT2Cleared 510(K)
- K071016DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT2Cleared 510(K)
- K071807ORTHOMEND SOFT TISSUE MATRIX2Cleared 510(K)
- K062558MESOSFOL SURGICAL FILM2Cleared 510(K)
- K070560LRTM SURGICAL MESH2Cleared 510(K)
- K071065ORTHADAPT BIOIMPLANT2Cleared 510(K)
- K070738SIS FACIAL CYLINDER, SIS FACIAL IMPLANT2Cleared 510(K)
- K063556PERIPATCH ENDO-SLEEVE2Cleared 510(K)
- K062915VERITAS COLLAGEN MATRIX2Cleared 510(K)
- K061892PROPATCH SOFT TISSUE REPAIR MATRIX2Cleared 510(K)
- K063178BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 11751062Cleared 510(K)
- K062696SURGISIS, SURGISIS ES2Cleared 510(K)
- K062729SURGISIS RVP RECTO-VAGINAL FISTULA PLUG2Cleared 510(K)
- K062320SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-1002Cleared 510(K)
- K053562ZIMMER COLLAGEN REPAIR PATCH2Cleared 510(K)
- K060984XENFORM SOFT TISSUE REPAIR MATRIX2Cleared 510(K)
- K060829COSMATRIX2Cleared 510(K)
- K060989TISSUEMEND SOFT TISSUE REPAIR MATRIX2Cleared 510(K)
- K061030BIOBLANKET SURGICAL MESH2Cleared 510(K)
- K052322BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 11751052Cleared 510(K)
- K053655TENDON WRAP TENDON PROTECTOR2Cleared 510(K)
- K051879SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS2Cleared 510(K)
- K051048SURGISIS STAPLE LINE REINFORCEMENT II2Cleared 510(K)
- K043259BIOBLANKET SURGICAL MESH2Cleared 510(K)
- K043388PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH2Cleared 510(K)
- K050246SIS DERMAL AUGMENTATION STRAND2Cleared 510(K)
- K050337SIS FISTULA PLUG2Cleared 510(K)
- K042809CUFFPATCH2Cleared 510(K)
- K041669VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD2Cleared 510(K)
- K041923BIOBLANKET2Cleared 510(K)
- K040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX2Cleared 510(K)
- K041140ACELL UBM SURGICAL MESH ML AND MLPLUS2Cleared 510(K)
- K040364MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH2Cleared 510(K)
- K040835PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P162Cleared 510(K)
- K040868SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH2Cleared 510(K)
- K033985PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C102Cleared 510(K)
- K040621ACELL UBM SURGICAL MESH2Cleared 510(K)
- K040119PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION2Cleared 510(K)
- K034039SIS PLASTIC SURGERY MATRIX2Cleared 510(K)
- K031969DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT2Cleared 510(K)
- K031332BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH2Cleared 510(K)
- K030782SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL2Cleared 510(K)
- K023237XYLOS SURGICAL MESH2Cleared 510(K)
- K021056PERMACOL2Cleared 510(K)
- K021160DERMMATRIX SURGICAL MESH2Cleared 510(K)
- K021107FORTAFLEX SURGICAL SLING2Cleared 510(K)
- K021105FORTAFLEX SURGICAL MESH2Cleared 510(K)
- K020455TISSUEMEND SOFT TISSUE REPAIR MATRIX2Cleared 510(K)
- K020049FORTAFLEX SURGICAL MESH2Cleared 510(K)
- K013625PERMACOL2Cleared 510(K)
- K011025FORTAFLEX SURGICAL MESH2Cleared 510(K)
- K011027FORTAFLEX SURGICAL SLING2Cleared 510(K)
- K001738DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT2Cleared 510(K)
- K991296TUTOPATCH2Cleared 510(K)
- K992537PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED2Cleared 510(K)
- K991567SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.2Cleared 510(K)
- K983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC2Cleared 510(K)
- K982330DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT2Cleared 510(K)
- K980431SURGISIS2Cleared 510(K)
- K973379STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS2Cleared 510(K)
- K971048PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT2Cleared 510(K)
- K963175GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING2Cleared 510(K)
- K961811PERI-GUARD PERICARDIUM2Cleared 510(K)
- K961810SUPPLE PERI-GUARD PERICARDIUM2Cleared 510(K)
- K940205PERI-STRIPS2Cleared 510(K)
- K922308TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER2Cleared 510(K)
- K923657SUPPLE PERI-GUARD2Cleared 510(K)
- K915774PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH2Cleared 510(K)
- K896946COATED NOVAFIL, POLYBUTESTER, MESH2Cleared 510(K)
- K894580GORE-TEX SURGICAL TAPE2Cleared 510(K)
- K852011NYLAMID MESH PAD FULL & HALF2Cleared 510(K)
- K851086VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH2Cleared 510(K)
- K844228PDS POLYDIOXANONE MESH2Cleared 510(K)
- K844225LINK ACETABULAR MESH2Cleared 510(K)
- K831725FOIL IN 3 FORMS-NON-STERILE SHEETS2Cleared 510(K)
- K831727QUARTER GLOBE CAPS2Cleared 510(K)
- K831723SUPRAMID EXTRA SURGICAL MESH2Cleared 510(K)
- K831726EYE MUSCLE SLEEVES2Cleared 510(K)
- K830889DEXON 'S' POLYGLYCOLIC ACID MESH2Cleared 510(K)
- K820619MECRON(R) ACETABULAR NETS TM2Cleared 510(K)
- FTNPlastic Surgery And Accessories Kit1Product Code
- FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3Product Code
- FWMProsthesis, Breast, Inflatable, Internal, Saline3Product Code
- FWPProsthesis, Chin, Internal2Product Code
- FYIAppliance, Facial Fracture, External1Product Code
- FZDProsthesis, Ear, Internal2Product Code
- FZEProsthesis, Nose, Internal2Product Code
- FZFSplint, Extremity, Inflatable, External1Product Code
- GBIMaterial, External Aesthetic Restoration, Used With Adhesive1Product Code
- GBJProsthesis, Adhesive, External1Product Code
- JCQProsthesis, Esophagus2Product Code
- KCZProsthesis, Breast, External, Used With Adhesive1Product Code
- KDAProsthesis, Ptfe/Carbon-Fiber2Product Code
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2Product Code
- LZKImplant, Malar2Product Code
- MCATape, Surgical, Internal2Product Code
- MNFImplant, Temporal2Product Code
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile1Product Code
- NODBoard, Arm (With Cover), Non-Sterile1Product Code
- NOJProsthesis, Breast, External, No Adhesive1Product Code
- NOKMaterial, External Aesthetic Restoration, No Adhesive1Product Code
- NWAProsthesis, Tracheal, Preformed/Molded2Product Code
- NYTProsthesis, Tracheal, Expandable, Polymeric2Product Code
- ODUFacial Implant2Product Code
- OXGMesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery2Product Code
- OODSurgical Film2Product Code
- OQLMesh, Surgical, Deployment Balloon2Product Code
- ORQMesh, Surgical, Deployer2Product Code
- OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery2Product Code
- OWSMesh, Surgical, Collagen, Plastics, Facial Implants2Product Code
- OWTMesh, Surgical, Absorbable, Abdominal Hernia2Product Code
- OWUMesh, Surgical, Non-Absorbable, Diaphragmatic Hernia2Product Code
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia2Product Code
- OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction2Product Code
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement2Product Code
- OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement2Product Code
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement2Product Code
- OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery2Product Code
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery2Product Code
- OXIMesh, Surgical, Absorbable, Large Abdominal Wall Defects2Product Code
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects2Product Code
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects2Product Code
- OXLMesh, Surgical, Absorbable, Organ Support2Product Code
- OXMMesh, Surgical, Absorbable, Fistula2Product Code
- OXNMesh, Surgical, Collagen, Fistula2Product Code
- PIJCollagen Surgical Mesh Containing Drugs2Product Code
- PQNCarbon Dioxide Gas Controlled Tissue Expander2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K182259
- 510(k) Type
- Traditional
- Applicant
- ACell, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/7/2019
- Days to Decision
- 170 days
- Submission Type
- Summary