Anesthesiology
Review Panel
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- 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
- HNOKeratome, Ac-Powered1Product Code
- HNPIntroducer, Sphere1Product Code
- HNQHook, Ophthalmic1Product Code
- HNRForceps, Ophthalmic1Product Code
- K022835STEPHENS DISPOSABLE FORCEPS1Cleared 510(K)
- K895434ALCON FOLDING FORCEPS1Cleared 510(K)
- K891487SOFT LENS FOLDING BLOCK1Cleared 510(K)
- K893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR1Cleared 510(K)
- K885230MCDONALD FOLDING FORCEPS1Cleared 510(K)
- K881049BRADBURY INTRAOCULAR RETINAL KIT CAT #2001Cleared 510(K)
- K883197IOL IMPLANTATION FORCEPS1Cleared 510(K)
- K880274ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS1Cleared 510(K)
- K864266OPHTHALMIC KNIFE & FORCEPS1Cleared 510(K)
- K864183OPHTHALMIC SURGICAL INSTRUMENTS1Cleared 510(K)
- K864071FAULKNER FORCEPS1Cleared 510(K)
- K863991THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND1Cleared 510(K)
- K863992THORNTON TITANIUM FORCEPS (VARIOUS TYPES)1Cleared 510(K)
- K864003PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS1Cleared 510(K)
- K863727FIXATION INSTRUMENTS1Cleared 510(K)
- K861141MANUAL OPHTHALMIC SURGICAL INSTRUMENTS1Cleared 510(K)
- K861057MANUAL OPHTHALMIC SURGICAL INSTRUMENTS1Cleared 510(K)
- K860915STORZ/MAZZACCO LENS FORCEP1Cleared 510(K)
- K854869INTRAOCULAR FORCEPS & SCISSORS1Cleared 510(K)
- K852057ASCON SURGICAL INSTRUMENTS1Cleared 510(K)
- K85179137-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS1Cleared 510(K)
- K85179237-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS1Cleared 510(K)
- K850119PHARMASEAL EYE PREP TRAY1Cleared 510(K)
- K844129SHURE GRIP TYING FORCEPS1Cleared 510(K)
- K843992CILCOR OPHTHALMIC INSTRUMENTS1Cleared 510(K)
- K842697ROOTMAN ORBITAL SURGERY INSTRUMENT SET1Cleared 510(K)
- K834355MICRO FORCEPS1Cleared 510(K)
- K823174MICROSURGICAL INSTRUMENTS1Cleared 510(K)
- K811658ANIS LENS IMPLANT FORCEPS #21Cleared 510(K)
- K803194FISHER-PICKERING INTRAOCULAR EYE MAGNET1Cleared 510(K)
- K801467DODICK LENS HOLDING FORCEPS1Cleared 510(K)
- K801465GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE1Cleared 510(K)
- K800368OPHTHALMIC FORCEPS1Cleared 510(K)
- K791986FIX. & LENS FOR. #'S 3510,3512,3248,37951Cleared 510(K)
- K771003LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS1Cleared 510(K)
- K770105SHEPARD II, LENS FORCEP W/ LOCK1Cleared 510(K)
- K770101SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK1Cleared 510(K)
- K770102HERSHMAN LENS FORCEPS W/OUT IRRIGATOR1Cleared 510(K)
- K770099SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK1Cleared 510(K)
- K770100BINKHORST LENS FORCEP W/ IRRIGATOR1Cleared 510(K)
- K770097HERSHMAN LENS FORCEPS WITH IRRIGATOR1Cleared 510(K)
- K770104BINKHORST LENS FORCEPS W/OUT IRRIGATOR1Cleared 510(K)
- K761251WECK TYING FORCEP, STRAIGHT TITANIUM1Cleared 510(K)
- K761252WECK TYING FORCEP, CURVED TITANIUM1Cleared 510(K)
- 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
ROOTMAN ORBITAL SURGERY INSTRUMENT SET
- Page Type
- Cleared 510(K)
- 510(k) Number
- K842697
- 510(k) Type
- Traditional
- Applicant
- DOWNS SURGICAL LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/7/1984
- Days to Decision
- 27 days