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
- K010305WEISS RETINAL CANNULA1Cleared 510(K)
- K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES1Cleared 510(K)
- K970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)1Cleared 510(K)
- K943932STERISEAL OPHTHALMIC CANNULA1Cleared 510(K)
- K942403INFUSION CANNULA1Cleared 510(K)
- K934844INTER TIP T1Cleared 510(K)
- K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECE1Cleared 510(K)
- K921488ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION1Cleared 510(K)
- K915074IRRIGATOR/ASPIRATOR PROBE1Cleared 510(K)
- K904074VITREORETINAL INFUSION CANNULA1Cleared 510(K)
- K901618OCULAR INFUSION CANNULA SYSTEM1Cleared 510(K)
- K890782GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)1Cleared 510(K)
- K882884STORZ INFUSION CANNULA1Cleared 510(K)
- K880346CANNULAS1Cleared 510(K)
- K880347ANESTHESIA/RETROBULBAR NEEDLES1Cleared 510(K)
- K875030OCU-11Cleared 510(K)
- K881487OPHTHALMIC CANNULA1Cleared 510(K)
- K875003PRISMA DISPOSABLE PUPIL CENTERING CANNULA1Cleared 510(K)
- K875002PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA1Cleared 510(K)
- K874994PRISMA DISPOSABLE ANGLED I/A CANNULA1Cleared 510(K)
- K874968PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA1Cleared 510(K)
- K874969PRISMA DISPOSABLE KRATZ CAPSULE POLISHER1Cleared 510(K)
- K874970PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA1Cleared 510(K)
- K874971PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS1Cleared 510(K)
- K874972PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA1Cleared 510(K)
- K874973PRISMA DISPOSABLE SIMCOE I/A CANNULA1Cleared 510(K)
- K874974PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER1Cleared 510(K)
- K874977PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED1Cleared 510(K)
- K874978PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA1Cleared 510(K)
- K874980PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER1Cleared 510(K)
- K874981PRISMA DISPOSABLE J-SHAPED I/A CANNULA1Cleared 510(K)
- K874982PRISMA DISPOSABLE SIMCOE EXTRACTOR1Cleared 510(K)
- K874984PRISMA DISPOSABLE MICRO IRRIGATING VECTUS1Cleared 510(K)
- K874985PRISMA DISPOSABLE CAPSULE POLISHER1Cleared 510(K)
- K874986PRISMA DISPOSABLE RETROBULBAR NEEDLE1Cleared 510(K)
- K874987PRISMA DISPOSABLE DOUBLE I/A CANNULA1Cleared 510(K)
- K874988PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT1Cleared 510(K)
- K874989PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS1Cleared 510(K)
- K874990PRISMA DISPOSABLE SILICONE BULB1Cleared 510(K)
- K874992PRISMA DISPOSABLE IRRIGATING LENS DIALER1Cleared 510(K)
- K874995PRISMA DISPOS. CURVED LACHRYMAL CANNULA1Cleared 510(K)
- K874996PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.1Cleared 510(K)
- K874998PRISMA DISPOSABLE U-SHAPED CANNULA1Cleared 510(K)
- K874999PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE1Cleared 510(K)
- K873853DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.01Cleared 510(K)
- K873164VAN DELLEN HEALON CANNULA1Cleared 510(K)
- K873162VAN DELLEN RETROBULBAR NEEDLE1Cleared 510(K)
- K872884LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH1Cleared 510(K)
- K872610SOLOS EYESITE CANNULAS1Cleared 510(K)
- K872200HAMACHER BULLET POINT OPHTHALMIC NEEDLE1Cleared 510(K)
- K872151OPHTHALMIC CANNULA1Cleared 510(K)
- K871605MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA1Cleared 510(K)
- K870902LOOK RETROBULBAR NEEDLES1Cleared 510(K)
- K870438LOOK IRRIGATING CANNULAS1Cleared 510(K)
- K870441LOOK CORTEX EXTRACTORS1Cleared 510(K)
- K870436LOOK IRRIGATING/ASPIRATING CANNULAS1Cleared 510(K)
- K861545IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES1Cleared 510(K)
- K860744OPTHALMIC SURGICAL INSTRUMENTS1Cleared 510(K)
- K854506STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA1Cleared 510(K)
- K854402THE NEW MCINTYRE I.A. HANDPIECE1Cleared 510(K)
- K854401THE NEW MOBILE TIP MCINTYRE CANNULA1Cleared 510(K)
- K853777THE NEW MCINTYRE CANNULA1Cleared 510(K)
- K852758INFUSION CANNULAM1Cleared 510(K)
- K843039SITE ANTERIOR CAPSULOTOMER1Cleared 510(K)
- K840442STERILIZED DISPOS. CYSTOTOME1Cleared 510(K)
- K831532OCULAR IRRIGATING CANNULA1Cleared 510(K)
- K831192INFUSION CANNULA1Cleared 510(K)
- K813314NLD IMPLANT SET1Cleared 510(K)
- K813481OMS INFUSION CANNULA ASSEMBLE1Cleared 510(K)
- K812010KOI LACRIMAL INTUBATION SYSTEM1Cleared 510(K)
- K811455ANIS GUIDING CANNULA1Cleared 510(K)
- K801411MAY ILLUMINATED/INFUSION PIC1Cleared 510(K)
- K791917X-PAK1Cleared 510(K)
- K791982CANNULA'S CAT #'S 6636, 6624, 66251Cleared 510(K)
- K782169NEEDLES, CANNULAS, CYSTOTOMES1Cleared 510(K)
- K790243CANNULAS1Cleared 510(K)
- K771416IRRIGATION/ASPIRATION NEEDLE1Cleared 510(K)
- 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
- 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
OCU-1
- Page Type
- Cleared 510(K)
- 510(k) Number
- K875030
- 510(k) Type
- Traditional
- Applicant
- RUDOLPH BEAVER, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/3/1988
- Days to Decision
- 148 days