BEUDAMED
    Product Code: OOW FDA class 1 21 CFR 876.4730

    Applicator For Rectal Suppository

    Gastroenterology, Urology

    The Applicator For Rectal Suppository (product code OOW) is a Class 1 device regulated under 21 CFR 876.4730 in the Gastroenterology, Urology specialty (GU), exempt from premarket notification. It is a simple device intended to facilitate the insertion of suppositories into the rectum, providing a controlled and hygienic means of delivery. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    OOW
    Device Class
    FDA class 1
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    Definition

    Intended for use in the insertion of suppositories into the rectum

    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
    K092829 INSERTEASE

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.