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

    Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

    K Number: K223612 · Decision Feb 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    4
    Review Days
    78

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    Basic Information

    Device Name
    Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
    K Number
    K223612
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ranfac Corporation
    Date Received
    December 5, 2022
    Decision Date
    February 21, 2023
    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 Ranfac Corporation

    K Number Device Name
    K202287 Ran-Flex-B Bone Marrow Aspiration Needle
    K190177 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
    K183146 Ranfac Cartilage Biopsy Needle