BEUDAMED
    Product Code: GCB FDA class 1 21 CFR 878.4200

    Needle, Catheter

    General, Plastic Surgery

    The Needle, Catheter (product code GCB) is a needle used to introduce or access a catheter into a vessel, body cavity, or tissue tract during general or plastic surgery procedures. 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 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    8
    FEI Numbers
    78
    Registration Numbers
    78
    Unique Applicants
    7
    Years Active
    37

    Basic Information

    Product Code
    GCB
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K150800 Valved Safety Centesis Catheter
    K974146 PARACENTESIS CATHETER DEVICE
    K930568 ADAIR/VERESS NEEDLE INTRODUCER SET
    K923028 TURKEL PNEUMOTHORAX KIT
    K900374 ADAIR/VERESS NEEDLE INTRODUCER SET
    K854327 SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
    K852428 MANAN EPIDURAL NEEDLE
    K780896 NEEDLES, DESIGN CHANGE, IV CATHETERS

    FEI Numbers

    This FDA classification entry is associated with 78 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 78 registration numbers. Click on an entry to view related FDA registrations.