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

    CORE-CLIP

    K Number: K213338 · Decision Jun 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    259

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    Basic Information

    Device Name
    CORE-CLIP
    K Number
    K213338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Incore Co., Ltd.
    Date Received
    October 7, 2021
    Decision Date
    June 23, 2022
    Product Code
    PKL
    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
    PKL Hemostatic Metal Clip For The Gi Tract

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    Other Clearances by Incore Co., Ltd.

    K Number Device Name
    K232216 Hemoblock_S (Prescription); Hemoblock_S (OTC)
    K221054 CORE-INJECTOR
    K220846 CORE-SNARE
    K220081 CORE-SPORT
    K211148 CORE-Trocar