BEUDAMED
    Product Code: QHC FDA class 2 21 CFR 876.1075

    Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

    Gastroenterology, Urology

    The Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs is a device used to obtain core soft tissue biopsy samples from internal female reproductive organs such as the uterus, ovaries, and retroperitoneal lymph nodes for pathological examination. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 876.1075 in the Gastroenterology and Urology specialty, reviewed by the Obstetrics/Gynecology panel. The product code is QHC. It is not an implant and is not life-sustaining.

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

    Product Code
    QHC
    Device Class
    FDA class 2
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

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

    Definition

    Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.