BEUDAMED
    Product Code: GDN FDA class 1 21 CFR 878.4800

    Knife, Amputation

    General, Plastic Surgery

    The Knife, Amputation (product code GDN) is a large surgical cutting instrument designed specifically for performing amputations, used to sever limbs or large tissue masses cleanly during major surgical procedures in general surgery. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GDN
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K851752 9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS

    FEI Numbers

    This FDA classification entry is associated with 68 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 68 registration numbers. Click on an entry to view related FDA registrations.