BEUDAMED
    Product Code: FDP FDA class 2 21 CFR 876.1500

    Apparatus, Pneumoperitoneum, Automatic

    Gastroenterology, Urology

    The Automatic Pneumoperitoneum Apparatus (product code FDP) is a device that automatically delivers and regulates gas pressure to distend the abdominal cavity during laparoscopic surgery, creating the working space necessary for the procedure. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FDP
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K910875 ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE

    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.