BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    THE KEYMED FIBERSCOPE STERILIZATION CASE

    K Number: K860528 · Decision Jul 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    29
    Review Days
    154

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    Basic Information

    Device Name
    THE KEYMED FIBERSCOPE STERILIZATION CASE
    K Number
    K860528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Keymed, Inc.
    Date Received
    February 11, 1986
    Decision Date
    July 15, 1986
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Keymed, Inc.

    K Number Device Name
    K100803 OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
    K921179 OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20
    K881004 OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
    K861821 KEYMED FIBERSCOPE AUTO DISINFECTOR
    K864801 THE KEYMED HI-LIGHT 250 LIGHT SOURCE
    K862000 KEYMED FLEXIBLE ESOPHAGEAL DILATORS
    K861147 UCS-2, ULTRASONIC CLEANING SOLUTION
    K860704 THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
    K851149 KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
    K854304 KEYMED OFFICE COUCH
    Search all 29 clearances from Keymed, Inc. →