BEUDAMED
    Product Code: FJY FDA class 1 21 CFR 876.5540

    Plier, Crimp

    Gastroenterology, Urology

    The Crimp Plier is a hand instrument used in conjunction with crimp rings to secure tubing connections in shunt or dialysis assemblies. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FJY, regulated under 21 CFR 876.5540 in the Gastroenterology and Urology specialty.

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    510(k)s
    0
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FJY
    Device Class
    FDA class 1
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.