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

    SURGICAL TROCAR AND CANNULA

    K Number: K904379 · Decision Dec 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    21
    Review Days
    87

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    Basic Information

    Device Name
    SURGICAL TROCAR AND CANNULA
    K Number
    K904379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Applied Vascular Devices, Inc.
    Date Received
    September 25, 1990
    Decision Date
    December 21, 1990
    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 Applied Vascular Devices, Inc.

    K Number Device Name
    K911730 SURGICAL OBTURATOR WITH SEAL
    K911589 DISPOSABLE SURGICAL TROCAR WITH SEAL
    K910339 AVD INTIMAX OCCLUSION CATHETER
    K910372 INTIMAX THROMBECTOMY CATHETER
    K911181 INTIMAX(TM) IRRIGATION CATHETER
    K910493 AVD INTIMAX CHOLANGIOGRAPHY CATHETER
    K903848 DIAGNOSTIC INTRASCULAR CATHETER
    K905738 OPERATIVE CHOLANGIOGRAPHIC CATHETER
    K910079 DISPOSABLE INTRODUCER SHEATH
    K902256 IRRIGATION CATHETER 4, 6 AND 10 FRENCH
    Search all 21 clearances from Applied Vascular Devices, Inc. →