BEUDAMED
    Product Code: PSF FDA class 2 21 CFR 876.5980

    Non-Balloon Replacement Gastrostomy System

    Gastroenterology, Urology

    The Non-Balloon Replacement Gastrostomy System is a convenience kit containing supplies for replacing a gastrostomy tube using a non-balloon retention mechanism, used in patients with established gastrostomies requiring tube replacement. It is classified as FDA Class 2 under 21 CFR 876.5980 in the Gastroenterology and Urology specialty. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PSF; not an implant and not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PSF
    Device Class
    FDA class 2
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    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.