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

    ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS

    K Number: K922391 · Decision Aug 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS
    K Number
    K922391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Instratek, Inc.
    Date Received
    May 20, 1992
    Decision Date
    August 18, 1992
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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