BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CORE-INJECTOR

    K Number: K221054 · Decision Dec 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    6
    Review Days
    254

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    Basic Information

    Device Name
    CORE-INJECTOR
    K Number
    K221054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Incore Co., Ltd.
    Date Received
    April 11, 2022
    Decision Date
    December 21, 2022
    Product Code
    FBK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

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    Other Clearances by Incore Co., Ltd.

    K Number Device Name
    K232216 Hemoblock_S (Prescription); Hemoblock_S (OTC)
    K220846 CORE-SNARE
    K220081 CORE-SPORT
    K213338 CORE-CLIP
    K211148 CORE-Trocar