BEUDAMED
    Product Code: GEJ FDA class 1 21 CFR 878.4800

    Carrier, Ligature

    General, Plastic Surgery

    The Carrier, Ligature (product code GEJ) is a manual surgical instrument used to pass suture material or ligatures around vessels or tissue structures during general and plastic surgery procedures to facilitate secure ligation. It is classified as an FDA Class 1 device, the lowest risk category, governed by general controls only and not requiring premarket notification. Regulated under 21 CFR 878.4800 within the General, Plastic Surgery specialty (SU), this device carries no special flags for implantation, life support, GMP exemption, or third-party review eligibility.

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    510(k)s
    5
    FEI Numbers
    70
    Registration Numbers
    71
    Unique Applicants
    4
    Years Active
    36

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    Basic Information

    Product Code
    GEJ
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K240185 Cypris eXact Suture Placement Device
    K900959 GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED
    K900958 GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM
    K884553 STAMEY NEEDLE
    K874342 LIGATURE CARRIER/PACKER, HYDROXYLAPATITE

    FEI Numbers

    This FDA classification entry is associated with 70 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.