BEUDAMED
    Product Code: FFF FDA class 1 21 CFR 876.1075

    Cover, Biopsy Forceps

    Gastroenterology, Urology

    The Biopsy Forceps Cover is a protective accessory that sheathes endoscopic biopsy forceps, preventing contamination or damage during insertion through the endoscope working channel. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is FFF, regulated under 21 CFR 876.1075, within the Gastroenterology, Urology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    FFF
    Device Class
    FDA class 1
    Regulation Number
    876.1075
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K892069 EXTENDED COVERS, STERILE

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.