Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EQLLaryngostroboscope1Product Code
- EOQBronchoscope (Flexible Or Rigid)2Product Code
- EOXEsophagoscope (Flexible Or Rigid)2Product Code
- BSTCurette, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- BWHForceps, Biopsy, Bronchoscope (Non-Rigid)2Product Code
- EMXBalloon, Epistaxis1Product Code
- ENWCatheter, Nasopharyngeal1Product Code
- ENZTelescope, Laryngeal-Bronchial2Product Code
- EOBNasopharyngoscope (Flexible Or Rigid)2Product Code
- EQHSource, Carrier, Fiberoptic Light1Product Code
- K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT1Cleared 510(K)
- K954184JED-LIGHT FIBEROPTIC LIGHT SOURCE1Cleared 510(K)
- K951829COLD LIGHT SOURCE LOS 1501Cleared 510(K)
- K932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE1Cleared 510(K)
- K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT1Cleared 510(K)
- K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT1Cleared 510(K)
- K934911SAPHIRE PLUS SURGICAL MIRROR1Cleared 510(K)
- K932131MID LABS TWIN ILLUMINATOR1Cleared 510(K)
- K930123ASPIRATING ENDO OCULAR PROBE1Cleared 510(K)
- K933145FIBEROPTIC LIGHTSOURCES AND CARRIERS1Cleared 510(K)
- K923227THROAT-A-SCOPE1Cleared 510(K)
- K923774DISPOSABLE ENDOILLUMINATOR1Cleared 510(K)
- K922095LX 150 LIGHT SOURCE1Cleared 510(K)
- K914586GRIESHABER THREE FUNCTION MANIPULATOR1Cleared 510(K)
- K914585GRIESHABER TWO FUNCTION MANIPULATOR1Cleared 510(K)
- K914247ASPIRATING ENDO OCULAR PROBE1Cleared 510(K)
- K912885KAPS 90 DEGREE FIBEROPTIC ADAPTOR1Cleared 510(K)
- K912767FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC1Cleared 510(K)
- K912522OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER1Cleared 510(K)
- K905437RIVER MEDICAL MICRODRILL SYSTEM1Cleared 510(K)
- K904378F.T.I. MEDICAL LIGHT GUIDE1Cleared 510(K)
- K904470SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE1Cleared 510(K)
- K902784FIBER OPTIC LIGHT SOURCE1Cleared 510(K)
- K896384FIBEROPTIC LIGHT SOURCE, FOI-1A1Cleared 510(K)
- K864387LUXTEC FIBEROPTIC CABLES1Cleared 510(K)
- K864383LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS1Cleared 510(K)
- K864382FRAZIER SUCTION TUBE1Cleared 510(K)
- K854751ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE1Cleared 510(K)
- K841731BRIMFIELD FIBEROPTIC LIGHT SCOURCE1Cleared 510(K)
- K831589VENT TUBE FORCEPS1Cleared 510(K)
- K831590T-TUBE INSERTER1Cleared 510(K)
- K823436MICROSURGICAL GAUGE1Cleared 510(K)
- K823437MCGEE 26GA. SUCTION TUBE1Cleared 510(K)
- K822259LARYNGEAL SPATULAS1Cleared 510(K)
- K822282FIBEROPTIC LIGHT CARRIERS1Cleared 510(K)
- K822192FIBEROPTIC LIGHT CARRIERS1Cleared 510(K)
- K822175ADAPTOR FOR FIBEROPTIC LIGHT SOURCE1Cleared 510(K)
- K820621NASAL INSTRUMENTS1Cleared 510(K)
- K812429DALE COMBO TRACHEOSTOMY TUBE HOLDER1Cleared 510(K)
- K802774FIBER OPTIC ADAPTER #60-08921Cleared 510(K)
- K802775FIBER OPTIC ADAPTER #60-08961Cleared 510(K)
- K802767FIBER OPTIC LIGHT GUIDE CAT#60-07681Cleared 510(K)
- K802766FIBER OPTIC ADAPTER CAT#60-08981Cleared 510(K)
- K802773FIBER OPTIC LIGHT GUIDE #60-07671Cleared 510(K)
- K802772FIBER OPTIC ADAPTER #60-08941Cleared 510(K)
- K802771FIBER OPTIC ADAPTER #60-8951Cleared 510(K)
- K802768FIBER OPTIC ADAPTER #60-08971Cleared 510(K)
- K801176FIBER OPTIC LIGHT SOURCE1Cleared 510(K)
- K760653ADAPTER/STANDARD FIBER OPTICS LIGHT1Cleared 510(K)
- EQJBur, Ear, Nose And Throat1Product Code
- EQNLaryngoscope, Nasopharyngoscope2Product Code
- ERAOtoscope1Product Code
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece2Product Code
- EWGLaser, Ent Microsurgical Carbon-Dioxide2Product Code
- EWQSaw, Surgical, Ent (Electric Or Pneumatic)1Product Code
- EWYMediastinoscope, Surgical2Product Code
- JEIClaw, Foreign Body, Bronchoscope (Non-Rigid)2Product Code
- JEJTubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)2Product Code
- JEKForceps, Biopsy, Bronchoscope (Rigid)2Product Code
- JELCurette, Biopsy, Bronchoscope (Rigid)2Product Code
- JYEChisel, Middle-Ear1Product Code
- JYFClamp, Ossicle Holding1Product Code
- JYGCurette, Ear1Product Code
- JYHExcavator, Ear1Product Code
- JYIGauge, Mastoid1Product Code
- JYJGauge, Measuring1Product Code
- JYLHook, Microsurgical Ear1Product Code
- JYMInserter, Myringotomy Tube1Product Code
- JYNInserter, Sacculotomy Tack1Product Code
- JYOKnife, Ear1Product Code
- JYPKnife, Myringotomy1Product Code
- JYQLoop, Wire1Product Code
- JYRNipper, Malleus1Product Code
- JYSPerforator, Ear-Lobe1Product Code
- JYTPick, Microsurgical Ear1Product Code
- JYWPress, Vein1Product Code
- JYXPunch, Attic1Product Code
- JYYRasp, Ear1Product Code
- JYZRod, Measuring Ear1Product Code
- JZARongeur, Mastoid1Product Code
- JZBScissors, Ear1Product Code
- JZCSearcher, Mastoid1Product Code
- JZDSnare, Ear1Product Code
- JZESpoon, Ear1Product Code
- JZFTube, Ear Suction1Product Code
- JZYKnife, Laryngeal1Product Code
- JZZSaw, Laryngeal1Product Code
- KAASet, Laryngeal Injection1Product Code
- KABTrocar, Laryngeal1Product Code
- KACTube, Laryngectomy1Product Code
- KADElevator, Ent1Product Code
- KAEForceps, Ent1Product Code
- KAHMicrorule, Ent1Product Code
- KAIMirror, Ent1Product Code
- KAJMobilizer, Ent1Product Code
- KAKProbe, Ent1Product Code
- KALRetractor, Ent1Product Code
- KAOCurette, Ethmoid1Product Code
- KAPCurette, Nasal1Product Code
- KAQGouge, Nasal, Ent1Product Code
- KARIrrigator, Sinus1Product Code
- KASKnife, Nasal1Product Code
- KATPerforator, Antrum1Product Code
- KAWPunch, Antrum1Product Code
- KAXPunch, Ethmoid1Product Code
- KAYPunch, Nasal1Product Code
- KAZRasp, Frontal-Sinus1Product Code
- KBARasp, Nasal1Product Code
- KBBRongeur, Nasal1Product Code
- KBCSaw, Nasal1Product Code
- KBDScissors, Nasal1Product Code
- KBESnare, Nasal1Product Code
- KBFTrephine, Sinus1Product Code
- KBGTrocar, Sinus1Product Code
- KBHAdenotome1Product Code
- KBIBougie, Eustachian1Product Code
- KBJCurette, Adenoid1Product Code
- KBKCurette, Salpingeal1Product Code
- KBLDepressor, Metal Tongue, Surgical1Product Code
- KBMDissector, Tonsil1Product Code
- KBNGag, Mouth1Product Code
- KBOGuillotine, Tonsil1Product Code
- KBPHook, Tonsil Suturing1Product Code
- KBQKnife, Tonsil1Product Code
- KBRNeedle, Tonsil Suturing1Product Code
- KBSPunch, Adenoid1Product Code
- KBTPunch, Tonsil1Product Code
- KBWScrew, Oral1Product Code
- KBXScrew, Tonsil1Product Code
- KBYSet, Filliform, Eustachian1Product Code
- KBZSnare, Tonsil1Product Code
- KCATonsillectome1Product Code
- KCBTube, Tonsil Suction1Product Code
- KCCBistoury, Tracheal1Product Code
- KCDBougie, Esophageal, Ent1Product Code
- KCFDilator, Esophageal, Ent1Product Code
- KCGDilator, Tracheal1Product Code
- KCHHook, Tracheal1Product Code
- KCITrocar, Tracheal1Product Code
- KTETrocar, Ent1Product Code
- KTFPunch, Ent1Product Code
- KTGKnife, Ent1Product Code
- KTIBronchoscope Accessory2Product Code
- KTRTube, Aspirating, Bronchoscope, Rigid2Product Code
- LJWTracheotome1Product Code
- LMSLaser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology2Product Code
- LRCInstrument, Ent Manual Surgical1Product Code
- LXRLaser, Microsurgical Argon, For Use In Otology2Product Code
- LYASplint, Intranasal Septal1Product Code
- MMOTray, Surgical, Ent1Product Code
- MQWTransilluminator, Fiber Optic1Product Code
- MXPBone Particle Collector1Product Code
- NLBTrocar, Tracheal, Laryngeal, Sinus, Reprocessed1Product Code
- NLEForceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed2Product Code
- NLYMicrodebrider, Ent, High Speed, Single Use, Reprocessed1Product Code
- NLZBur, Ent, Diamond Coated, Single Use, Reprocessed1Product Code
- OGREar, Nose, And Throat Surgical Tray1Product Code
- OGUPierced Ear/Entry Cleaning Tray1Product Code
- PNZEustachian Tube Balloon Dilation Device2Product Code
- QGKBalloon, Nasal Airway1Product Code
- QJLSplint, Intranasal Septal, Cber Led1Product Code
- QNWReprocessed Bronchoscope2Product Code
- QQHPowered Insertion System For A Cochlear Implant Electrode Array2Product Code
- OLLSeptal Stapler/Absorbable Staples2Product Code
- SBSLaryngeal Injection Set With Led Light1Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K912522
- 510(k) Type
- Traditional
- Applicant
- SUMMIT TECHNOLOGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/25/1991
- Days to Decision
- 64 days
- Submission Type
- Statement