BEUDAMED
    Product Code: FBW FDA class 1 21 CFR 876.5520

    Filiform And Filiform Follower

    Gastroenterology, Urology

    The Filiform and Filiform Follower (product code FBW) is a flexible urethral instrument system in which a slender filiform guide is passed through tight strictures, followed by a larger follower dilator to progressively widen the passage. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.5520 in the Gastroenterology and Urology specialty. No special flags apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FBW
    Device Class
    FDA class 1
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    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
    K912839 LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.