BEUDAMED
    Product Code: LWE FDA class 2

    Bone Marrow Collection/Transfusion Kit

    Unknown

    The Bone Marrow Collection/Transfusion Kit (product code LWE) is a convenience kit used for the collection and reinfusion of bone marrow, typically in the context of bone marrow transplantation or autologous procedures. Classified as a Class 2 device, it was established under FDA's 1997 convenience kit guidance and does not require a 510(k) if it meets all criteria set out in that guidance, meaning it is under enforcement discretion. The kit is reviewed under the Hematology (HO) panel and has no formal medical specialty designation. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    3
    Years Active
    8

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    Basic Information

    Product Code
    LWE
    Device Class
    FDA class 2
    Medical Specialty
    Unknown
    Review Panel
    HO
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K952350 JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
    K913306 BONE-TEMNO/STERNUM-TEMNO
    K871198 BONE MARROW COLLECTION KIT AND STAND

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.