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

    cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

    K Number: K251852 · Decision Feb 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    241

    Basic Information

    Device Name
    cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
    K Number
    K251852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VPIX Medical, Inc.
    Date Received
    June 17, 2025
    Decision Date
    February 13, 2026
    Product Code
    OWN
    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
    OWN Confocal Optical Imaging

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    Other Clearances by VPIX Medical, Inc.

    K Number Device Name
    K233391 cCeLL - In vivo