BEUDAMED
    Product Code: GAK FDA class 2 21 CFR 878.4830

    Suture, Absorbable

    General, Plastic Surgery

    The Suture, Absorbable (product code GAK) is a surgical suture material that is designed to be gradually broken down and absorbed by the body over time, eliminating the need for removal after wound healing. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The device is regulated under 21 CFR 878.4830 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is placed within body tissue during surgical wound closure.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GAK
    Device Class
    FDA class 2
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K914365 DEXON DISSECTING SPONGE