BEUDAMED
    Product Code: GBP FDA class 1 21 CFR 878.4200

    Catheter, Multiple Lumen

    General, Plastic Surgery

    The Catheter, Multiple Lumen (product code GBP) is a catheter constructed with two or more internal channels (lumens), allowing simultaneous infusion and aspiration or delivery of multiple fluids during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    3
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    3
    Years Active
    3

    Basic Information

    Product Code
    GBP
    Device Class
    FDA class 1
    Regulation Number
    878.4200
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K844889 MENSINK-GOOSEN CATHETER
    K821220 MULTILUMEN INTRAVENOUS INFUSION CATHETER
    K820446 CATHETER, MULTIPLE LUMEN

    FEI Numbers

    This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.