BEUDAMED
    Product Code: GDT FDA class 1 21 CFR 878.4760

    Staple, Removable (Skin)

    General, Plastic Surgery

    The Staple, Removable (Skin) (product code GDT) is a metallic staple applied to close skin incisions or lacerations following surgery, designed for external use on the skin surface and intended to be removed once healing is complete. It is classified as FDA Class 1, the lowest risk level, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4760 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    View on FDA
    510(k)s
    19
    FEI Numbers
    100
    Registration Numbers
    100
    Unique Applicants
    15
    Years Active
    20

    Basic Information

    Product Code
    GDT
    Device Class
    FDA class 1
    Regulation Number
    878.4760
    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 19 510(k) clearances via K numbers.

    K Number Device Name
    K963234 STAPLE REMOVAL KIT
    K943719 VISISTAT STAPLER
    K925526 MANIPLER DISPOSABLE SKIN STAPLER
    K915430 SKIN STAPLE REMOVER KIT
    K911204 QUALTEX SKIN STAPLE EXTRACTOR
    K910586 AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
    K900486 APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
    K861711 SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE
    K851974 V. MUELLER VITAL SKIN STAPLER
    K844838 SKIN STAT II SKIN STAPLING MEDICAL DEVICE
    K844837 VISISTAT SKIN STAPLING DEVICE
    K833085 STAPLE REMOVER SR300P
    K833357 VYDAX 525-550 & 5100 FLUOROTELOMER
    K832709 SKIN STAPLING DEVICE SC2000
    K822365 CENTURION SKIN STAPLE REMOVER
    K821024 DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE
    K801444 SKIN STAPLE REMOVER #523770
    K800535 3M DISPOSABLE SKIN STAPLER
    K760734 REGULAR AND WIDE SKIN STAPLES

    FEI Numbers

    This FDA classification entry is associated with 100 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 100 registration numbers. Click on an entry to view related FDA registrations.