BEUDAMED
    Product Code: FDE FDA class 2 21 CFR 876.1500

    Laparoscopy Kit

    Gastroenterology, Urology

    The Laparoscopy Kit (product code FDE) is a convenience kit assembling the components needed to perform laparoscopic procedures, such as trocars, cannulas, and accessories. It is an FDA Class 2 device (moderate risk) established under the May 20, 1997 Convenience Kits Interim Regulatory Guidance; kits meeting all criteria in that guidance are under enforcement discretion and may not require a 510(k). It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

    View on FDA
    510(k)s
    4
    FEI Numbers
    40
    Registration Numbers
    40
    Unique Applicants
    4
    Years Active
    5

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    Basic Information

    Product Code
    FDE
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K955717 ENDOSCOPE INTRODUCER KIT
    K950924 ASLAN KNOT PUSHER
    K942677 GEENEN/ZEBRA GUIDELINES
    K912443 CANDELA INTRODUCER SHEATH SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.