BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SUCTION BIOPSY INSTRUMENT

    K Number: K895420 · Decision Feb 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    46
    Review Days
    161

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    Basic Information

    Device Name
    SUCTION BIOPSY INSTRUMENT
    K Number
    K895420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mill-Rose Laboratory
    Date Received
    September 1, 1989
    Decision Date
    February 9, 1990
    Product Code
    FCK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCK Instrument, Biopsy, Suction

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    Other Clearances by Mill-Rose Laboratory

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    K971275 MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
    K962736 MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
    K960880 MILL-ROSE BLIND MICROBIOLOGY BRUSH
    K954519 WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
    K951600 MILL-ROSE ROTATABLE POLYPECTOMY SNARE
    K954745 MILL-ROSE RIGID SCOPE CLEANING BRUSHES
    K951051 RITE-BITE BIOPSY FORCEPS
    K951048 RITE-BITE BIOPSY FORCEPS
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