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

    CORE-Trocar

    K Number: K211148 · Decision Jun 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    428

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    Basic Information

    Device Name
    CORE-Trocar
    K Number
    K211148
    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 19, 2021
    Decision Date
    June 21, 2022
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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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
    K213338 CORE-CLIP