Anesthesiology
Review Panel
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- 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
- K241150MISTI Silicone Implant2Cleared 510(K)
- K223051Pre-Formed Silicone Block2Cleared 510(K)
- K222748ShiNeo Silicone Implant2Cleared 510(K)
- K200073AugMENTA Penile Implant2Cleared 510(K)
- K220760Pre-Formed Penile Silicone Block2Cleared 510(K)
- K193392BioSiCar Silicone Implant2Cleared 510(K)
- K181387Pre-Formed Penile Silicone Block2Cleared 510(K)
- K171851SOFTXIL2Cleared 510(K)
- K162624Pre-Formed Penile Silicone Block2Cleared 510(K)
- K052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X2Cleared 510(K)
- K052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X2Cleared 510(K)
- K042054SILIMED PECTORAL IMPLANT2Cleared 510(K)
- K042380SILICONE BLOCK2Cleared 510(K)
- K040042MEDISIL SILICONE SHEETING2Cleared 510(K)
- K030809HANSON MEDICAL GLUTEAL IMPLANT2Cleared 510(K)
- K030808HANSON MEDICAL CALF IMPLANT2Cleared 510(K)
- K022511AART CALF IMPLANT2Cleared 510(K)
- K022223AART SILICONE SHEETING2Cleared 510(K)
- K021839AART GLUTEAL IMPLANT2Cleared 510(K)
- K021820AART SILICONE CARVING BLOCK2Cleared 510(K)
- K983630SEARE BIOMEDICAL SILICONE RODS2Cleared 510(K)
- K982688SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK2Cleared 510(K)
- K983041SEARE BIOMEDICAL SILICONE SHEETING2Cleared 510(K)
- K982065STERILE SILICONE EXTERNAL WOUND COVER2Cleared 510(K)
- K981851SILIMED SILICONE CARVING BLOCK2Cleared 510(K)
- K974653SILICONE ELASTOMER SHEETING2Cleared 510(K)
- K974654SILICONE BLOCKS2Cleared 510(K)
- K974480SILIMED CALF IMPLANT2Cleared 510(K)
- K974482SILIMED GLUTEAL IMPLANT2Cleared 510(K)
- K973730DURASIL I AND DURASIL II2Cleared 510(K)
- K973166DOW CORNING SILASTIC ELASTOMER Q7-47502Cleared 510(K)
- K973728SILICONE CARVING BLOCK2Cleared 510(K)
- K971480DURALASTIC I AND DURALASTIC II2Cleared 510(K)
- K971613SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING2Cleared 510(K)
- K961081SPIRIT RIDGE SILICONE CARVING BLOCK2Cleared 510(K)
- K961057DURALASTIC SHEETING II2Cleared 510(K)
- K960038SPECTRUM DESIGNS SILICONE BLOCK2Cleared 510(K)
- K955368DURALASTIC I2Cleared 510(K)
- K955370DURALASTIC II2Cleared 510(K)
- K954382PROLASTIC SHEETING2Cleared 510(K)
- K952732MEDICAL GRADE SILICONE BLOCK2Cleared 510(K)
- K945552DURALASTIC SHEETING2Cleared 510(K)
- K935571DURALASTIC SHEETING2Cleared 510(K)
- K944408IMPLANTECH MEDICAL GRADE SILICONE SHEETING2Cleared 510(K)
- K913882ZARA SILICONE BLOCK2Cleared 510(K)
- 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
- 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
STERILE SILICONE EXTERNAL WOUND COVER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K982065
- 510(k) Type
- Traditional
- Applicant
- SPECIALTY SURGICAL PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/12/1998
- Days to Decision
- 61 days
- Submission Type
- Statement