BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENDOPROBES

    K Number: K922917 · Decision Sep 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    5
    Review Days
    103

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    Basic Information

    Device Name
    ENDOPROBES
    K Number
    K922917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endooptiks, Inc.
    Date Received
    June 17, 1992
    Decision Date
    September 28, 1992
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Endooptiks, Inc.

    K Number Device Name
    K083788 ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
    K042918 MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
    K003151 MICROPOBE SERIES OF LASERS AND ACCESSORIES
    K945081 TRANSTYMPANIC ENDOSCOPE