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

    Pegasus System

    K Number: K191345 · Decision Jul 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    Pegasus System
    K Number
    K191345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A.M. Surgical, Inc.
    Date Received
    May 20, 2019
    Decision Date
    July 17, 2019
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    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
    HRX Arthroscope

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