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

    CellFX System

    K Number: K222075 · Decision Sep 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    7
    Review Days
    50

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    Basic Information

    Device Name
    CellFX System
    K Number
    K222075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulse Biosciences, Inc.
    Date Received
    July 14, 2022
    Decision Date
    September 2, 2022
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Pulse Biosciences, Inc.

    K Number Device Name
    K240782 CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)
    K233705 CellFX Percutaneous Electrode System (SYS3000)
    K213674 CellFX System
    K221671 CellFX® System
    K211444 CellFX System
    K203299 CellFX System