BEUDAMED
    Product Code: PPC FDA class 2 21 CFR 876.5130

    Male External Catheterization Kit (Excludes Hiv Testing)

    Gastroenterology, Urology

    The Male External Catheterization Kit is a convenience kit combining supplies for non-invasive external urinary catheterization in male patients, used in the Gastroenterology and Urology specialty. It is classified as FDA Class 2 under regulation 21 CFR 876.5130. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PPC; not an implant and not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PPC
    Device Class
    FDA class 2
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    7

    Device Characteristics

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

    Definition

    This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.