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

    PROCTOSCOPE #501

    K Number: K790856 · Decision May 29, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    25

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    Basic Information

    Device Name
    PROCTOSCOPE #501
    K Number
    K790856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    C. Intl.
    Date Received
    May 4, 1979
    Decision Date
    May 29, 1979
    Product Code
    GCF
    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
    GCF Proctoscope

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GCF), ordered by most recent decision date.

    PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
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    Other Clearances by C. Intl.

    K Number Device Name
    K792494 CATHETERIZATION FORCEP
    K790855 SURGICAL DRAPE CLIP #201
    K790853 EASY-SPEC
    K790852 VAGI-SPEC
    K790851 VAGI-PRESS #401
    K790854 FORCEPS #101 AND #102