Anesthesiology
Review Panel
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- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
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- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- HLDEngine, Trephine, Accessories, Gas-Powered1Product Code
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered2Product Code
- FCTHeadlight, Fiberoptic Focusing2Product Code
- FSRLight, Headband, Surgical2Product Code
- FTZLocator, Magnetic1Product Code
- HMQMarker, Sclera1Product Code
- HMRMarker, Ocular1Product Code
- HMSDrum, Eye Knife Test1Product Code
- HMXCannula, Ophthalmic1Product Code
- HMYKeratome, Battery-Powered1Product Code
- HMZTrabeculotome1Product Code
- HNASpud, Ophthalmic1Product Code
- HNBSpoon, Ophthalmic1Product Code
- HNCSpecula, Ophthalmic1Product Code
- HNDSpatula, Ophthalmic1Product Code
- HNESnare, Enucleating1Product Code
- HNFScissors, Ophthalmic1Product Code
- HNGRongeur, Lachrymal Sac1Product Code
- HNHRing, Ophthalmic (Flieringa)1Product Code
- HNIRetractor, Ophthalmic1Product Code
- HNJPunch, Corneo-Scleral1Product Code
- HNKProbe, Trabeculotomy1Product Code
- HNLProbe, Lachrymal1Product Code
- HNMNeedle, Ophthalmic Suturing1Product Code
- HNNKnife, Ophthalmic1Product Code
- K110166CLEARCUT S SAFETY KNIFE1Cleared 510(K)
- K922378OPHTHALMIC KNIFE1Cleared 510(K)
- K882402RETRACTIVE INCISION MICROMETER (RIM) GUAGE1Cleared 510(K)
- K881669MVR/STILETTO BLADE 20GA. - P/N 19001Cleared 510(K)
- K874979PRISMA DISPOSABLE MVR/STILETTO BLADE1Cleared 510(K)
- K874057OPHTHALMIC TIP & BLADE SCALPELS1Cleared 510(K)
- K874056OPHTHALMIC DISPOSABLE BLADES1Cleared 510(K)
- K873385OPHTHALMIC PHACO-BLADE1Cleared 510(K)
- K871285KNIFE, OPHTHALMIC1Cleared 510(K)
- K864290RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE1Cleared 510(K)
- K863725CATARACT DIAMOND KNIFE1Cleared 510(K)
- K863665THE ULTIMATE1Cleared 510(K)
- K861744SAPPHIRE KNIFE BLADE1Cleared 510(K)
- K861748RUBY & SAPPHIRE BLADE HOLDER1Cleared 510(K)
- K861732STORZ E9050 & E9055 DIAMOND KNIVES1Cleared 510(K)
- K861491ROPHAE DIAMOND KNIFE1Cleared 510(K)
- K861334CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE1Cleared 510(K)
- K860852SAPPHIRE BLADE SURGICAL KNIFE1Cleared 510(K)
- K855050STORZ E9040 & E9046 DIAMOND KNIVES1Cleared 510(K)
- K860332DIAMOND BLADE MICROMETER KNIFE1Cleared 510(K)
- K860331DISPOSABLE SURGICAL KNIFE1Cleared 510(K)
- K860305BEAVER MICRO-GEM GAUGE BLOCK1Cleared 510(K)
- K853598OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE1Cleared 510(K)
- K853403STORZ DIAMOND KNIFE1Cleared 510(K)
- K853063SMARTKNIFE SYSTEM1Cleared 510(K)
- K852828BEAVER R-K KNIFE1Cleared 510(K)
- K852706VERSABLADE1Cleared 510(K)
- K852633VERSABLADE1Cleared 510(K)
- K853499MICRON-SCOPE1Cleared 510(K)
- K853129BEAVER MULTIPURPOSE SAPPHIRE KNIFE1Cleared 510(K)
- K85179037-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN1Cleared 510(K)
- K842647CATARACT TRAY1Cleared 510(K)
- K850049KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA1Cleared 510(K)
- K844553MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE1Cleared 510(K)
- K843447CILCO DIAMOND KNIFE1Cleared 510(K)
- K841951MICROSURGICAL KNIFE1Cleared 510(K)
- K840855CORNEAL SCLERAL LANCE1Cleared 510(K)
- K834546SURGICAL KNIFE1Cleared 510(K)
- K832844RUBY KNIVES FOR OPHTH. SURGERY1Cleared 510(K)
- K831975LEADING EDGE OPHTHALMIC KNIFE1Cleared 510(K)
- K831266MICROSURGICAL KNIFE1Cleared 510(K)
- K830366DIAMOND KNIFE1Cleared 510(K)
- K822112OPHTHALMIC KNIFE1Cleared 510(K)
- K821440V LANCE1Cleared 510(K)
- K820618MICROSURGERY KNIFE1Cleared 510(K)
- K812918PILLING K KNIFE1Cleared 510(K)
- K812620ADJUSTABLE MICROSURGICAL KNIFE1Cleared 510(K)
- K812450KOI DIAMOND KNIFE1Cleared 510(K)
- K791981SWAN KNIFE NEEDLE 1.5MM CAT # 11701Cleared 510(K)
- K791980TOME'S #'S 1221,1222,1223,1314,6640,66421Cleared 510(K)
- K781465MICROSURGICAL KNIVES, 20, 30, 451Cleared 510(K)
- K760186DISSECTOR, TROUTMAN CORNEAL1Cleared 510(K)
- K760191KNIFE, TROUTMAN CORNEAL LARGE1Cleared 510(K)
- K760187KNIFE, TROUTMAN CORNEAL SMALL1Cleared 510(K)
- HNOKeratome, Ac-Powered1Product Code
- HNPIntroducer, Sphere1Product Code
- HNQHook, Ophthalmic1Product Code
- HNRForceps, Ophthalmic1Product Code
- HNSExpressor1Product Code
- HNTErisophake1Product Code
- HNWDilator, Lachrymal1Product Code
- HNXDepressor, Orbital1Product Code
- HNYCystotome1Product Code
- HNZCurette, Ophthalmic1Product Code
- HOACompressor, Orbital1Product Code
- HOBClamp, Muscle, Ophthalmic1Product Code
- HOCClip, Iris Retractor1Product Code
- HODClamp, Eyelid, Ophthalmic1Product Code
- HOECaliper, Ophthalmic1Product Code
- HOFBurr, Corneal, Manual1Product Code
- HOGBurr, Corneal, Battery-Powered1Product Code
- HOHSpectacle, Operating (Loupe), Ophthalmic1Product Code
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1Product Code
- HOZSponge, Ophthalmic2Product Code
- HPMLocator, Metal, Electronic2Product Code
- HPNMagnet, Permanent1Product Code
- HPOMagnet, Ac-Powered2Product Code
- HPPHeadlamp, Operating, Battery-Operated1Product Code
- HPQHeadlamp, Operating, Ac-Powered2Product Code
- HPSUnit, Cryophthalmic2Product Code
- HPYUnit, Electrolysis, Battery-Powered, Ophthalmic1Product Code
- HQAUnit, Cryotherapy, Ophthalmic2Product Code
- HQBPhotocoagulator And Accessories2Product Code
- HQCUnit, Phacofragmentation2Product Code
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2Product Code
- HQFLaser, Ophthalmic2Product Code
- HQOUnit, Cautery, Thermal, Ac-Powered2Product Code
- HQPUnit, Cautery, Thermal, Battery-Powered2Product Code
- HQQApparatus, Cautery, Radiofrequency, Battery-Powered2Product Code
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered2Product Code
- HQSBurr, Corneal, Ac-Powered1Product Code
- HRFEngine, Trephine, Accessories, Battery-Powered1Product Code
- HRGEngine, Trephine, Accessories, Ac-Powered1Product Code
- HRHTrephine, Manual, Ophthalmic1Product Code
- HRJTable, Instrument, Powered, Ophthalmic1Product Code
- HRKTable, Instrument, Manual, Ophthalmic1Product Code
- HRNUnit, Cryophthalmic, Ac-Powered2Product Code
- HROUnit, Electrolysis, Ac-Powered, Ophthalmic2Product Code
- HRPPen, Marking, Surgical1Product Code
- KYBLens, Guide, Intraocular1Product Code
- KYGDevice, Irrigation, Ocular Surgery1Product Code
- LCCApplicator, Ocular Pressure2Product Code
- LPOGases Used Within Eye To Place Pressure On Detached Retina3Product Code
- LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser2Product Code
- LWLFluid, Intraocular3Product Code
- LXPPlug, Scleral2Product Code
- LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla2Product Code
- LZPAid, Surgical, Viscoelastic3Product Code
- MLZVitrectomy, Instrument Cutter2Product Code
- MMCDilator, Expansive Iris (Accessory)2Product Code
- MOECollagen Corneal Shield1Product Code
- MSRTubing, Replacement, Phacofragmentation Unit2Product Code
- MSSFolders And Injectors, Intraocular Lens (Iol)1Product Code
- MUSFluidic, Phacoemulsification/Phacofragmentation2Product Code
- MXOLaser, System, Phacolysis2Product Code
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal1Product Code
- MYDKeratome, Water Jet1Product Code
- NCEInjector, Capsular Tension Ring1Product Code
- NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered2Product Code
- NGYCannula, Trocar, Ophthalmic1Product Code
- NKXNeedle, Phacoemulsification, Reprocessed2Product Code
- NKYBlade, Keratome, Reprocessed1Product Code
- NLAKnife, Ophthalmic, Reprocessed1Product Code
- NVBIntraocular, Pressure Measuring Device3Product Code
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal1Product Code
- OHXBurr, Corneal, Ac-Powered, Rust Ring Removal1Product Code
- OJKEye Tray2Product Code
- OOEOphthalmic Femtosecond Laser2Product Code
- OTZGraft Insertion Instrument For Endothelial Keratoplasty1Product Code
- PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered2Product Code
- PZGSurgical Eye Tray1Product Code
- QDVIol Tray1Product Code
- QDWPhaco Kit2Product Code
- QDYVitrectomy Kit2Product Code
- QGJCorneal Inlay Inserter Handle1Product Code
- QQQGuide And Positioner, Ophthalmic Drug Delivery Device1Product Code
- PYUSponge, Eyelid Cleaning, Powered1Product Code
- QUQKnife, Intraocular Pressure Lowering2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SMARTKNIFE SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K853063
- 510(k) Type
- Traditional
- Applicant
- COOPERVISION, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 11/4/1985
- Days to Decision
- 108 days