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
- EQJBur, Ear, Nose And Throat1Product Code
- EQNLaryngoscope, Nasopharyngoscope2Product Code
- ERAOtoscope1Product Code
- K123821AIO HD OTOSCOPE1Cleared 510(K)
- K121326LANTOS 3D EAR SCANNER1Cleared 510(K)
- K110326OSRAM ITOS1Cleared 510(K)
- K945264OPTUS OTOSCOPES1Cleared 510(K)
- K955043WELCH ALLYN BI-OTOSCOPE1Cleared 510(K)
- K952578WELCH ALLY OTOSCOPE1Cleared 510(K)
- K950913PERFECT, ENT SET, PRAKTIKANT, DE LUXE1Cleared 510(K)
- K950788OTOSCOPE A-341Cleared 510(K)
- K951050SPECULUM, ENT (S3)1Cleared 510(K)
- K951049SPECULUM, ENT (S3)1Cleared 510(K)
- K951255IMEDGE VIDEO OSTOSCOPE (ANALOG)1Cleared 510(K)
- K950983IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE1Cleared 510(K)
- K950787WELCH ALLYN OTOSCOPE1Cleared 510(K)
- K946043H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG1Cleared 510(K)
- K943721OTOVIEW TELESCOPIC OTOSCOPES1Cleared 510(K)
- K944897HOME CARE EAR EXAMINATIO KIT1Cleared 510(K)
- K943731VIDEO OTOSCOPE1Cleared 510(K)
- K944031VIDEO SCOPE SYSTEM (OTOSCOPE)1Cleared 510(K)
- K943916VIDEOTOSCOPE1Cleared 510(K)
- K942244REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE1Cleared 510(K)
- K941659AURAL-CAM, VIDEO EAR, VID RX1Cleared 510(K)
- K932259CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE1Cleared 510(K)
- K932503RI-MINI1Cleared 510(K)
- K932506RI-SCOPE (S)1Cleared 510(K)
- K932505RI-STAR1Cleared 510(K)
- K925752STANDARD1Cleared 510(K)
- K925753UNI III1Cleared 510(K)
- K925758OTOSCOPE1Cleared 510(K)
- K925759UNI I1Cleared 510(K)
- K923830XOMED-TREACE ALPHASCOPE1Cleared 510(K)
- K924025OTO-BRITE HANDLE1Cleared 510(K)
- K923304FAMILY EAR SCOPE MODEL 29001S1Cleared 510(K)
- K922752STARKEY LABORATORIES OTOSCOPE1Cleared 510(K)
- K920322OPTIEAR1Cleared 510(K)
- K913348THE STERN ERA SYSTEM1Cleared 510(K)
- K915537EARBEAR OTOSCOPE1Cleared 510(K)
- K911650PEDIA PALS1Cleared 510(K)
- K904659DR. DEDO'S FAMILY EAR EXAMINATION KIT1Cleared 510(K)
- K904802VIDEO OTOSCOPE1Cleared 510(K)
- K902205OTOSCOPE1Cleared 510(K)
- K896274TYMPANOSCOPE1Cleared 510(K)
- K862661D.L. SCOPE(R) OTOSCOPE1Cleared 510(K)
- K862621I22 INITIALES1Cleared 510(K)
- K862624I81 CITE1Cleared 510(K)
- K8517451-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B1Cleared 510(K)
- K8517461-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.1Cleared 510(K)
- K840593DISPOSA-SPEC1Cleared 510(K)
- K831614INSPETOSCOPE1Cleared 510(K)
- K831709AUDIOSCOPE #23000 W/71123 CHARGING STAND1Cleared 510(K)
- K813305CONPHAR OTOSCOPE1Cleared 510(K)
- K813299CONPHAR OTOSCOPE/OPTHALMASCOPE1Cleared 510(K)
- K813003P.P.P. TREATMENT CABINET1Cleared 510(K)
- K800365EARSCOPE1Cleared 510(K)
- K782142ILLIMINATOR, MODEL 265 NASAL1Cleared 510(K)
- K781029OTOSCOPE, DIAG. MODELS 20100 & 202001Cleared 510(K)
- K770770WALL CHARGER, MODEL #791111Cleared 510(K)
- K770769OTOSCOPE/ILLUMINATOR, MODEL #211001Cleared 510(K)
- 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
- 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
IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K950983
- 510(k) Type
- Traditional
- Applicant
- INTROSPECT, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/12/1995
- Days to Decision
- 40 days
- Submission Type
- Summary