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

    SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT

    K Number: K964450 · Decision Jan 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    5
    Review Days
    65

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    Basic Information

    Device Name
    SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
    K Number
    K964450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pilling Weck Group
    Date Received
    November 6, 1996
    Decision Date
    January 10, 1997
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by Pilling Weck Group

    K Number Device Name
    K971334 PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
    K965176 PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
    K964123 REUSABLE TROCAR WITH SLEEVE (COMMON)
    K963815 REUSABLE TROCAR WITH SLEEVE (COMMON)