BEUDAMED
    Product Code: GDH FDA class 1 21 CFR 878.4800

    Gouge, Surgical, General & Plastic Surgery

    General, Plastic Surgery

    The Gouge, Surgical, General and Plastic Surgery (product code GDH) is a curved or straight chisel-like instrument with a concave blade, used to scoop or carve bone or cartilage during general or plastic surgery procedures such as rhinoplasty or otoplasty. It is classified as FDA Class 1, posing the lowest level of risk, requiring only general controls and no 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.

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    510(k)s
    6
    FEI Numbers
    159
    Registration Numbers
    159
    Unique Applicants
    4
    Years Active
    14

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    Basic Information

    Product Code
    GDH
    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 6 510(k) clearances via K numbers.

    K Number Device Name
    K903419 MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
    K900487 MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
    K891901 GOUGES, ALEXANDER, BISHOP, LUCAS
    K874879 AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE
    K842822 CHERMEL BONE GOUGES
    K760850 PARKES HUMP GAUGE STRAIGHT 7 (18 CM)

    FEI Numbers

    This FDA classification entry is associated with 159 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 159 registration numbers. Click on an entry to view related FDA registrations.