BEUDAMED
    Product Code: QFZ FDA class 1 21 CFR 876.1080

    Gastroenterology-Urology Accessories To A Biopsy Instrument

    Gastroenterology, Urology

    The Gastroenterology-Urology Accessories To A Biopsy Instrument are manual accessories used to remove a specimen of tissue for microscopic examination by cutting or aspiration, including syringes for specimen aspiration and biopsy channel adaptors, specifically for use in gastroenterological and urological procedures. It is classified as FDA Class 1, with no premarket notification required, under regulation 876.1080 in the Gastroenterology and Urology specialty. The product code is QFZ. It is not an implant and is not life-sustaining.

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

    Basic Information

    Product Code
    QFZ
    Device Class
    FDA class 1
    Regulation Number
    876.1080
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    Definition

    A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.

    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.