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

    Cytrellis Dermal Micro-Coring System

    K Number: K202517 · Decision Jul 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    311

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    Basic Information

    Device Name
    Cytrellis Dermal Micro-Coring System
    K Number
    K202517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4430
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cytrellis Biosystems, Inc.
    Date Received
    September 1, 2020
    Decision Date
    July 9, 2021
    Product Code
    QAI
    Advisory Committee
    General, Plastic Surgery
    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
    QAI Powered Microneedle Device

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    Other Clearances by Cytrellis Biosystems, Inc.

    K Number Device Name
    K252752 ellacor System with Micro-Coring Technology