BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    TRAP EASY

    K Number: K242029 · Decision Oct 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    TRAP EASY
    K Number
    K242029
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    H.S Hospital Service S.P.A
    Date Received
    July 11, 2024
    Decision Date
    October 9, 2024
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

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    Other Clearances by H.S Hospital Service S.P.A

    K Number Device Name
    K232072 AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
    K182605 HS AMICA devices family
    K150112 HS AMICA DEVICES FAMILY
    K083157 HS AMICA
    K033616 TRAPMATIC SYSTEM SET