BEUDAMED
    Product Code: EMD FDA class 1 21 CFR 872.4565

    Hemostat, Surgical

    Dental

    The Surgical Hemostat is a dental hand instrument with locking, ratcheted handles and serrated beaks used to clamp blood vessels, grasp tissue, and apply hemostatic pressure to control bleeding during oral surgical procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EMD, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    119
    Registration Numbers
    119
    Unique Applicants
    2
    Years Active
    15

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    Basic Information

    Product Code
    EMD
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K920883 HEMOSTAT, SURGICAL (VARIOUS TYPES)
    K770158 HEMOSTAT

    FEI Numbers

    This FDA classification entry is associated with 119 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 119 registration numbers. Click on an entry to view related FDA registrations.