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
- FTNPlastic Surgery And Accessories Kit1Product Code
- FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3Product Code
- FWMProsthesis, Breast, Inflatable, Internal, Saline3Product Code
- FWPProsthesis, Chin, Internal2Product Code
- K232593FITme Customized Silicone Implant2Cleared 510(K)
- K200610Customized Contour Implant2Cleared 510(K)
- K191130Customized Contour Implant2Cleared 510(K)
- K191916Stryker CMF MEDPOR Priority Customized Implant Kit2Cleared 510(K)
- K153508Stryker CMF MEDPOR Customized Implant2Cleared 510(K)
- K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant2Cleared 510(K)
- K143173Stryker CMF MEDPOR Customized Implant2Cleared 510(K)
- K1410273D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP2Cleared 510(K)
- K121315STRYKER CMF MEDPOR CUSTOMIZED IMPLANT2Cleared 510(K)
- K091011PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)2Cleared 510(K)
- K021417AART CHIN IMPLANT2Cleared 510(K)
- K012350MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL2Cleared 510(K)
- K992239PILLAR CHIN IMPLANT2Cleared 510(K)
- K983754STANDARD CHIN2Cleared 510(K)
- K982752SEARE BIOMEDICAL CHIN IMPLANTS2Cleared 510(K)
- K981850SILIMED CHIN IMPLANTS2Cleared 510(K)
- K980446SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT2Cleared 510(K)
- K980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT2Cleared 510(K)
- K980462SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT2Cleared 510(K)
- K980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT2Cleared 510(K)
- K980444SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT2Cleared 510(K)
- K980138SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT2Cleared 510(K)
- K980461SPECTRUM DESIGNS CLEFT CHIN IMPLANT2Cleared 510(K)
- K973575DURALASTIC ANATOMICAL CHIN IMPLANTS2Cleared 510(K)
- K971478DURALASTIC ANATOMICAL CHIN IMPLANTS2Cleared 510(K)
- K961071THE MAGNUM CHIN IMPLANT2Cleared 510(K)
- K960349PERMARIDGE HYDROXYLAPATITE MATRIX2Cleared 510(K)
- K952677MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL2Cleared 510(K)
- K946267GORE-TEX SAM FACIAL IMPLANT2Cleared 510(K)
- K945998CHIN IMPLANT STYLE I2Cleared 510(K)
- K925610FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN2Cleared 510(K)
- K931500THE PERMARIDGE MATRIX CHIN2Cleared 510(K)
- K943644IMPLANTECH TEMPORAL IMPLANT2Cleared 510(K)
- K942280GORETEX SAM FACIAL IMPLANT2Cleared 510(K)
- K933367GORE-TEX FACIAL IMPLANT2Cleared 510(K)
- K922489MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA2Cleared 510(K)
- K921581CHIN WAFER2Cleared 510(K)
- K914297K.D. CHIN IMPLANT2Cleared 510(K)
- K9137613-D ACCUSCAN FACIAL IMPLANTS2Cleared 510(K)
- K911516HIGH PROFILE CHIN IMPLANT2Cleared 510(K)
- K911514ARTICULATED CHIN IMPLANT2Cleared 510(K)
- K910458ZARA SOFT TIP CHIN IMPLANT2Cleared 510(K)
- K910456ZARA CHIN IMPLANT2Cleared 510(K)
- K910457ZARA EXTENDED CHIN IMPLANT2Cleared 510(K)
- K905268FLOWERS JOWL IMPLANT2Cleared 510(K)
- K905267FLOWERS CHIN IMPLANT2Cleared 510(K)
- K904349CUI CURVILINEAR SILICONE CHIN2Cleared 510(K)
- K902285THE MAGNUM CHIN IMPLANT2Cleared 510(K)
- K903327CUI ARTICULATED SILICONE CHIN2Cleared 510(K)
- K902941CURVILINEAR SILICONE CHIN IMPLANT2Cleared 510(K)
- K902824EXTENDED CHIN IMPLANT STYLE I2Cleared 510(K)
- K902827ANATOMICAL MANDIBULAR IMPLANT STYLE II2Cleared 510(K)
- K902826ANATOMICAL MANDIBULAR IMPLANT STYLE I2Cleared 510(K)
- K902825EXTENDED CHIN IMPLANT STYLE II2Cleared 510(K)
- K871070OMEGA SILICONE CHIN IMPLANT2Cleared 510(K)
- K871190ANADIAS ZARA SYSTEM MALAR IMPLANTS2Cleared 510(K)
- K871074OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR2Cleared 510(K)
- K863941POREX(TM) PROSTHESIS, CHIN, INTERNAL2Cleared 510(K)
- K863397BYRON SILICONE CHIN IMPLANTS2Cleared 510(K)
- K832283MEDPAR SURGICAL IMPLANTS2Cleared 510(K)
- K832148PDM SILOXANE PROSTHETIC CHIN IMPLANT2Cleared 510(K)
- K831724CHIN (MENTOPLASTY) IMPLANTS2Cleared 510(K)
- K812210CREAT BRAND WAGNER CHIN IMPLANT2Cleared 510(K)
- K801073STRAITH CHIN IMPLANTS2Cleared 510(K)
- K760562CHIN IMPLANTS2Cleared 510(K)
- 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
GORETEX SAM FACIAL IMPLANT
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K942280
- 510(k) Type
- Traditional
- Applicant
- W.L. GORE & ASSOCIATES,INC
- Country
- United States
- FDA Decision
- Substantially Equivalent - Subject to Tracking Regulation
- Decision Date
- 7/28/1994
- Days to Decision
- 79 days
- Submission Type
- Summary