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
- 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
- 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
- K212763UniVit HE, UniVit UHS2Cleared 510(K)
- K170183Cetus system, Cetus probe2Cleared 510(K)
- K153168Bi-Blade Vitrectomy Cutter2Cleared 510(K)
- K141065CONSTELLATION VISION SYSTEM2Cleared 510(K)
- K121675VERSAVIT2Cleared 510(K)
- K120170PROCARE PLUS VITRECTOMY SYSTEM2Cleared 510(K)
- K102222ULTIMATE VIT ENHAMCER (UVE)2Cleared 510(K)
- K033390COLIBRI DISPOSABLE VITRECTOMY CUTTER2Cleared 510(K)
- K030948VMATE MODEL VMM10002Cleared 510(K)
- K023939VELOCITY ADVANTAGE2Cleared 510(K)
- K020911MID LABS AUTONOMOUS VIT ENHANCER (AVE)2Cleared 510(K)
- K010082D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM2Cleared 510(K)
- K992943VIT ENHANCER2Cleared 510(K)
- K990292I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN2Cleared 510(K)
- K983797D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM2Cleared 510(K)
- K980399PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.202Cleared 510(K)
- K980400PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.102Cleared 510(K)
- K980488STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM2Cleared 510(K)
- K970670REUSABLE VITRECTOMY PROBE2Cleared 510(K)
- K970673DISPOSABLE VITRECTOMY PROBE2Cleared 510(K)
- K964743STORZ E8010 ERGOTEC/PREMIERE ADAPTOR2Cleared 510(K)
- K961738VIT COMMANDER SYSTEM2Cleared 510(K)
- K960061STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE2Cleared 510(K)
- K961078AUTOMATED VITRECTOMY DEVICE2Cleared 510(K)
- K954816STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX2Cleared 510(K)
- K953575STORZ MVS-3201 VITRECTOMY PROBE PACK2Cleared 510(K)
- K953576STORZ DP4505 VITREOUS MEMBRANE DISSECTOR2Cleared 510(K)
- K950852CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)2Cleared 510(K)
- K950799PRO-VIT2Cleared 510(K)
- K946135INFINITECH ASPIRATING LASER PROBE2Cleared 510(K)
- K946181INFINITECH SOFT TIP FLUTE NEEDLE2Cleared 510(K)
- K934600MICRODRIVE2Cleared 510(K)
- K936302NIDEK MODEL VT-4000, MODIFICATION2Cleared 510(K)
- K940391PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE2Cleared 510(K)
- K940746VIT CUTTER MODEL 942Cleared 510(K)
- K932669SUPRA-VIT(TM)2Cleared 510(K)
- K930842THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE2Cleared 510(K)
- K933907STORZ FIBEROPTIC PICK MANIPULATOR2Cleared 510(K)
- K932668OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER2Cleared 510(K)
- K934204INTERTIP INFUSION SET2Cleared 510(K)
- K933984STORZ FIBEROPTIC REVERSE CUTTING KNIFE2Cleared 510(K)
- K933208BARE-FIBER ENDOILLUMINATOR2Cleared 510(K)
- K924353NIDEK MODEL VST-40002Cleared 510(K)
- K924222MID LABS, INC. VIT MATE2Cleared 510(K)
- K924604STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV2Cleared 510(K)
- K922355POLLY'S VITREOUS SCISSORS J-225-S2Cleared 510(K)
- K921758STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM2Cleared 510(K)
- K921460STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS2Cleared 510(K)
- K920718DISPOSABLE POSTERIOR MICROSCISSORS2Cleared 510(K)
- K920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.2Cleared 510(K)
- K915745D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE2Cleared 510(K)
- K913504STORZ MICRO CUTTER 25 GAUGE PACK2Cleared 510(K)
- K913261DWYER EYE SYSTEMS ASPIRATION UNIT2Cleared 510(K)
- K912384DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE2Cleared 510(K)
- K914038POLLY'S CUTTER J-2252Cleared 510(K)
- K913837MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM2Cleared 510(K)
- K914221KPE 220 TS, NONSTERILE2Cleared 510(K)
- K912253LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING2Cleared 510(K)
- K911998MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM2Cleared 510(K)
- K910973DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE2Cleared 510(K)
- K904909I/A VITROPHAGE MODEL YPR 20012Cleared 510(K)
- K895813GLAUCOMA MECHANICAL TREPHINE2Cleared 510(K)
- K896943SITE DISPOSABLE CUTTER AND ACCESSORIES2Cleared 510(K)
- K894248CONVERTER SYSTEM2Cleared 510(K)
- K896754I/A HANDPIECE2Cleared 510(K)
- K896305MULTI-USE I/A HANDPIECE2Cleared 510(K)
- K894278STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS2Cleared 510(K)
- K890195JAMES SURGICAL SYSTEM J10002Cleared 510(K)
- K891601POWER OPERATED AND CONTROLLED VITREOUS SCISSORS2Cleared 510(K)
- K884557ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE2Cleared 510(K)
- K890622SURG-E-TROL SYSTEM I AND SYSTEM II2Cleared 510(K)
- K890300INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE2Cleared 510(K)
- K890133OCULAR CONNECTION MACHINE(TM)2Cleared 510(K)
- K890544SHAPIRO CUTTER2Cleared 510(K)
- K884556DREYER CURVED ENDOILLUMINATOR2Cleared 510(K)
- K885196LASER INDIRECT OPHTHALMOSCOPE (LIO)2Cleared 510(K)
- K884043GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE2Cleared 510(K)
- K883926.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.2Cleared 510(K)
- K883975DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.2Cleared 510(K)
- K883605MODIFIED REUSABLE SITE FIBER OPTIC CABLE2Cleared 510(K)
- K881519VAC-G (GUILLOTINE VITRECTOR)2Cleared 510(K)
- K881520VAC (OSCILLATING VITRECTOR)2Cleared 510(K)
- K880943MICROLINE CAT #1002Cleared 510(K)
- K881927PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES2Cleared 510(K)
- K880929NIDEK CV-40002Cleared 510(K)
- K880968MODEL 2001 PHACOEMULSIFIER ASPIRATOR2Cleared 510(K)
- K872312MODEL 3000 OPHTHALMIC SURGICAL SYSTEM2Cleared 510(K)
- K871871SERIES TEN THOUSAND OCUTOME2Cleared 510(K)
- K871375SITE PERISTALTIC MODULE SYSTEM2Cleared 510(K)
- K870775ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE2Cleared 510(K)
- K870068ASPIRATION REVERSAL CONTROL (ARC) MODULE2Cleared 510(K)
- K864035VES-10 INTRAOCULAR SCISSORS DRIVE2Cleared 510(K)
- K862943SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE2Cleared 510(K)
- K862188IRRIGATION & ASPIRATION/VITRECTOMY DEVICE2Cleared 510(K)
- K862343VACUUM HANDLE MODEL I/A - 12Cleared 510(K)
- K861565SERIES TEN THOUSAND COMPACT2Cleared 510(K)
- K861380SERIES TEN THOUSAND MASTER2Cleared 510(K)
- K860891AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE2Cleared 510(K)
- K860014SYSTEMS PLUS2Cleared 510(K)
- K854868I/A - VFE SYSTEM II2Cleared 510(K)
- K854871MICRO SURGICAL SYSTEM2Cleared 510(K)
- K834160VITREONIC PLUS2Cleared 510(K)
- K834162VIT PAC2Cleared 510(K)
- K854508STORZ DAISY2Cleared 510(K)
- K853430STORZ IAS DISPOSABLE PACK2Cleared 510(K)
- K853961VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 1002Cleared 510(K)
- K853457COBURN I/A SYSTEM2Cleared 510(K)
- K853382MAID MENTOR ASPIRATION/IRRIGATION DEVRO2Cleared 510(K)
- K853308KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 50002Cleared 510(K)
- K851936STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT2Cleared 510(K)
- K853135VISITEC 2 MICRON FLUID FILTER2Cleared 510(K)
- K852271CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 90012Cleared 510(K)
- K851610COMBINED MVS SYSTEMS2Cleared 510(K)
- K851272VERSAPHAGE2Cleared 510(K)
- K843594AIRVIT MODEL 85002Cleared 510(K)
- K850857I/A HANDPIECE2Cleared 510(K)
- K844715VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY2Cleared 510(K)
- K843391INFUSION ASPIRATION VITRECTOMY SYS2Cleared 510(K)
- K842793MVS XII2Cleared 510(K)
- K844510OMS SCISSORS2Cleared 510(K)
- K844374O.M.S. GUILLOTINE CUTTER2Cleared 510(K)
- K842188MULTIPLE-LENS, SPECTACLES, CUSTOM2Cleared 510(K)
- K843041HESLIN DISPOS. TUBING SET2Cleared 510(K)
- K842471AUTOMATED INTRAOCULAR SCISSORS2Cleared 510(K)
- K841738AMER. SURGICAL CORP. EXTRA PLUS PAK2Cleared 510(K)
- K842197AMERICAN MEDICAL OPTICS I/A KIT- IRRIG2Cleared 510(K)
- K834155UNIVERSAL PACK2Cleared 510(K)
- K834437KEATES IRRIGATION/ASPIRATION/VITREOUS2Cleared 510(K)
- K832703ARGON LASER SYS-MODEL 50002Cleared 510(K)
- K833371DISPOSABLE OCUTOME PROBE2Cleared 510(K)
- K834163ULTRAVIT2Cleared 510(K)
- K832446CATAREX DIAP. EXTRACAPSULAR CATARACT2Cleared 510(K)
- K832235DISPOSABLE VITRECTOMY HANDPIECE2Cleared 510(K)
- K831584BAILEY ASPIRATOR/IRRIGATOR2Cleared 510(K)
- K830037EXTENSION HANDLE FOR ACUTOME PROBE2Cleared 510(K)
- K830216DORC COMPACT MICRO SURGICAL SYSTEM2Cleared 510(K)
- K822220COOPER VISION I/A SYSTEM III MODEL 15002Cleared 510(K)
- K820933CILCO I/A HANDPIECE2Cleared 510(K)
- K820008VERSATOME I2Cleared 510(K)
- K820026VITRE CON2Cleared 510(K)
- K813274BLOOD POOL & SUBVETINAL FLUID ASPIRATOR2Cleared 510(K)
- K812857CHARLES MICRO PROBE2Cleared 510(K)
- K813500OMS INFUSION-ASPIRATION HANDLE2Cleared 510(K)
- K813389ULTRASONIC FRAGMENTOR2Cleared 510(K)
- K801850CHARLES PNEUMATIC INTRAOCULAR SCISSORS2Cleared 510(K)
- K800110X-FLO2Cleared 510(K)
- K791212VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG2Cleared 510(K)
- K781471PNEUMATIC VITRECTOMY CONTROL UNIT2Cleared 510(K)
- K771711BIOTOME2Cleared 510(K)
- 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
AUTOMATED VITRECTOMY DEVICE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K961078
- 510(k) Type
- Traditional
- Applicant
- Promex, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/14/1996
- Days to Decision
- 88 days
- Submission Type
- Statement