BEUDAMED
    Product Code: FGM FDA class 1 21 CFR 876.4730

    Probe And Director, Gastro-Urology

    Gastroenterology, Urology

    The Gastro-Urology Probe and Director is a manual surgical instrument used to guide, probe, or direct tissue or instruments during gastroenterological and urological surgical procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is FGM, regulated under 21 CFR 876.4730, within the Gastroenterology, Urology medical specialty.

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    510(k)s
    7
    FEI Numbers
    107
    Registration Numbers
    107
    Unique Applicants
    3
    Years Active
    10

    Basic Information

    Product Code
    FGM
    Device Class
    FDA class 1
    Regulation Number
    876.4730
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K041732 CAVERMAP SURGICAL AID
    K031527 MODIFICATION TO CAVERMAP SURGICAL AID
    K010098 MODIFICATION TO CAVERMAP SURGICAL AID
    K993436 CAVERMAP SURGICAL AID
    K944384 ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
    K944379 ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG
    K944378 ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG

    FEI Numbers

    This FDA classification entry is associated with 107 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 107 registration numbers. Click on an entry to view related FDA registrations.