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

    Ran-Flex-B Bone Marrow Aspiration Needle

    K Number: K202287 · Decision Sep 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    198
    Registration Numbers
    198
    Same Product Code
    353
    Applicant Total
    4
    Review Days
    37

    Basic Information

    Device Name
    Ran-Flex-B Bone Marrow Aspiration Needle
    K Number
    K202287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ranfac Corporation
    Date Received
    August 12, 2020
    Decision Date
    September 18, 2020
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNW), ordered by most recent decision date.

    Disposable Biopsy Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ExpressCore Biopsy Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Ranfac Corporation

    K Number Device Name
    K223612 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
    K190177 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,
    K183146 Ranfac Cartilage Biopsy Needle