BEUDAMED
    Product Code: KGG FDA class 3

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    Unknown

    Tissue Adhesive for Use in Embolization of Brain Arteriovenous Malformations is a liquid embolic agent injected into the feeding vessels of cerebral arteriovenous malformations to occlude abnormal vascular connections and reduce the risk of hemorrhage, as part of endovascular neurosurgical treatment. It is classified as FDA Class 3, the highest risk category, reflecting the high-risk neurovascular application; devices in this class require Premarket Approval (PMA), demonstrating a reasonable assurance of safety and effectiveness through clinical evidence. The product code is KGG; no regulation number or medical specialty code is assigned.

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    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KGG
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.