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
- MVFSystem, Laser, Photodynamic Therapy3Product Code
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy3Product Code
- MWZExpander, Breast, ExternalUProduct Code
- MYHSystem, Non-Coherent Light, Photodynamic Therapy3Product Code
- NBESealant, Polymerizing3Product Code
- PBDComposite Cultured SkinFProduct Code
- QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions2Product Code
- MTJWax, BoneUProduct Code
- DTHSuture, Cardiovascular3Product Code
- DZGSuture, Dental3Product Code
- EFQGauze/Sponge, InternalUProduct Code
- EYFProtector, Wound, PlasticUProduct Code
- FRODressing, Wound, DrugUProduct Code
- GELGauze/Sponge, Internal, With Drug/Biologic, Animal Source MaterialUProduct Code
- GERGauze, External (With Drug/Biologic/Animal Source Material)UProduct Code
- HMNSuture, Nonabsorable, Ophthalmic3Product Code
- HMOSuture, Absorbable, Ophthalmic3Product Code
- KGMSilicone, Liquid, Injectable3Product Code
- KGNDressing, Wound, CollagenUProduct Code
- LCJExpander, Skin, InflatableUProduct Code
- K254126Natrelle 133S Tissue ExpandersUCleared 510(K)
- K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsUCleared 510(K)
- K243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderUCleared 510(K)
- K241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderUCleared 510(K)
- K211676Motiva Flora SmoothSilk Tissue ExpanderUCleared 510(K)
- K214124AlloX2 Pro Tissue ExpandersUCleared 510(K)
- K221127Sientra, inc. PortfinderUCleared 510(K)
- K180826Natrelle 133 Plus MICROCELL Tissue ExpanderUCleared 510(K)
- K182335CPX 4 Breast Tissue Expander with Smooth SurfaceUCleared 510(K)
- K182054Natrelle 133S Tissue ExpanderUCleared 510(K)
- K161483Unger Quad InjectorUCleared 510(K)
- K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceUCleared 510(K)
- K152496CPX 4 Breast Tissue ExpanderUCleared 510(K)
- K143354Natrelle 133 Plus Tissue ExpanderUCleared 510(K)
- K150777Artoura Breast Tissue ExpanderUCleared 510(K)
- K142998CPX Control Breast Tissue ExpanderUCleared 510(K)
- K140383ALLOX2 TISSUE EXPANDERSUCleared 510(K)
- K131692BLOSSOM SALINE DELIVERY ASSIST DEVICEUCleared 510(K)
- K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSUCleared 510(K)
- K112534LIFECELL TISSUE EXPANDERUCleared 510(K)
- K102806NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABSUCleared 510(K)
- K070303SILICONE TISSUE EXPANDERUCleared 510(K)
- K011500MENTOR CONTOUR PROFILE TISSUE EXPANDERUCleared 510(K)
- K983385HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERSUCleared 510(K)
- K983792SEARE BIOMEDICAL SILICONE TISSUE EXPANDERUCleared 510(K)
- K981852SILIMED TISSUE EXPANDERUCleared 510(K)
- K982067MAGNETIC PORT SILICONE TISSUE EXPANDERUCleared 510(K)
- K974209SILICONE TISSUE/INFLATABLE TISSUE EXPANDERUCleared 510(K)
- K963066MENTOR INJECTION PORT DETECTOR (IPD)UCleared 510(K)
- K913772PRESSURE GUARDUCleared 510(K)
- K914095PEEPERS TANNING GOGGLESUCleared 510(K)
- K904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERUCleared 510(K)
- K905484ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORTUCleared 510(K)
- K903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERUCleared 510(K)
- K894475MENTOR TISSUE EXPANDERS W/TDMAC COATINGUCleared 510(K)
- K894495SURGITEK(R) EXTERNAL FILL PORTUCleared 510(K)
- K884746SURGITEK FLAT T-SPANUCleared 510(K)
- K884250RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)UCleared 510(K)
- K883485STRYKER PRESSURE MONITOR SYSTEMUCleared 510(K)
- K883303MENTOR RAPID-SPAN (TM) TISSUE EXPANDERUCleared 510(K)
- K874276CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDERUCleared 510(K)
- K865056CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDERUCleared 510(K)
- K870754MCGHAN TISSUE EXPANDER FILL SYSTEMUCleared 510(K)
- K870154POREX(TM) TISSUE EXPANDERUCleared 510(K)
- K865033BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDERUCleared 510(K)
- K864185MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGNUCleared 510(K)
- K864184MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGNUCleared 510(K)
- K862203MCGHAN MAGNA-SITE(TM) TISSUE EXPANDERUCleared 510(K)
- K862049MENTOR FLAT-SPANUCleared 510(K)
- K854794MCGHAN INTEGRAL VALVE TISSUE EXPANDERUCleared 510(K)
- K853014MCGHAN TISSUE EXPANDER FILL KITUCleared 510(K)
- K845036TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600UCleared 510(K)
- K844813MENTOR EXPANDER MAMMARY PROSTHESISUCleared 510(K)
- K843678CREAT BRAND SKIN EXPANDERUCleared 510(K)
- K843704MCGHAN TISSUE EXPANDERUCleared 510(K)
- K842883RADOVAN TISSUE EXPANDERUCleared 510(K)
- K840464TISSUE EXPANDERUCleared 510(K)
- K833502RADOVAN SUBCUTANEOUS TISSUE EXPANDERUCleared 510(K)
- K801042SILASTIC BRAND PERCUTANEOUS SKIN EXPANDEUCleared 510(K)
- K790842SUBCUTANEOUS TISSUE EXPANDERUCleared 510(K)
- K771224RADOVAN SUBCUTANEOUS TISSUE EXPANDERUCleared 510(K)
- LFLInstrument, Ultrasonic SurgicalUProduct Code
- LMHImplant, Dermal, For Aesthetic Use3Product Code
- LMIImplant, Collagen For Non-Aesthetic Use3Product Code
- LRQTracheostomy And Nasal Suctioning Kit1Product Code
- LRRFirst Aid Kit With DrugNProduct Code
- LXULaser For Wound Healing3Product Code
- MAWMarker, Suture IdentificationUProduct Code
- MDDDevice, Dermal Replacement3Product Code
- MGPDressing, Wound And Burn, OcclusiveUProduct Code
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUProduct Code
- MGRDressing, Wound And Burn, Interactive3Product Code
- MQZProsthesis, NailUProduct Code
- MRDSizer, Mammary, Breast Implant VolumeUProduct Code
- MSADressing, Wound And Burn, Occlusive, HeatedUProduct Code
- NLQScalpel, Ultrasonic, ReprocessedUProduct Code
- NQKMaggots, MedicalUProduct Code
- NRNLeeches, MedicinalUProduct Code
- NSSElectronic Media, NauseaNProduct Code
- NZFStatic Electricity-Emitting Device, Cosmetic UseNProduct Code
- OCECultured Epithelial AutograftFProduct Code
- ODSWound Covering (Composite Cultured Skin)FProduct Code
- OEEDiagnostic Low Electric Field3Product Code
- OJIBurn Kit With DrugNProduct Code
- ONVElectrical Impedance Spectrometer3Product Code
- OYDOptical Diagnostic Device For Melanoma Detection3Product Code
- PFCCultured Human Cell Skin Dressing3Product Code
- PHUIntra-Abdominal Pressure Monitoring DeviceUProduct Code
- PKYImplant, Dermal, For Aesthetic Use In The Hands3Product Code
- PUVLymph Node Location System During Sentinel Biopsy Procedure3Product Code
- PZCAblation System, High Intensity Focus Ultrasound (Hifu), Soft TissueNProduct Code
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)NProduct Code
- QQFSkin Microneedling Manual/Automated Device (Export Only)NProduct Code
- QVSBreast Implant Suction Retrieval Device2Product Code
- QVXSkin Patch For Treatment Of Hyperhidrosis2Product Code
- PLJTissue Adhesive Internal Use3Product Code
- QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUProduct Code
- QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUProduct Code
- QSZAbsorbable Synthetic Wound DressingUProduct Code
- QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation2Product Code
- QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer2Product Code
- SABTable Mounted Miniaturized Electromechanical Surgical System2Product Code
- SAQElectromechanical System For Open Microsurgery2Product Code
- SAWFluorescence Imaging For Breast Cancer Detection3Product Code
- QMLAnal Fistula Closure Device2Product Code
- SAHMagnetic Compression Anastomosis System2Product Code
- QYKSemi-Automated Autologous Skin Graft Harvesting And Application Device2Product Code
- SCVModular Electromechanical Surgical System2Product Code
- SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field2Product Code
- SEJWound Dressings Containing Topical AnalgesicsUProduct Code
- SEKWound Dressings With HydrocortisoneUProduct Code
- SELSecurement Wound Dressing For Reduction Of InfectionUProduct Code
- QXWCryoablation Device For Local Treatment Of Low-Risk Breast Cancer2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- 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
CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K865056
- 510(k) Type
- Traditional
- Applicant
- COX-UPHUFF INTL.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/22/1987
- Days to Decision
- 149 days