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

    ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE

    K Number: K010303 · Decision Sep 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    280

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
    K Number
    K010303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Artscan Medical Innovations
    Date Received
    December 5, 2000
    Decision Date
    September 11, 2001
    Product Code
    NGR
    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
    NGR Tester, Stiffness, Cartilage, Arthroscopic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NGR), ordered by most recent decision date.

    ACTAEON PROBE

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all