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

    HardyDisk AST Gepotidacin 10µg (GEP10)

    K Number: K260842 · Decision May 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    327
    Applicant Total
    109
    Review Days
    56

    Basic Information

    Device Name
    HardyDisk AST Gepotidacin 10µg (GEP10)
    K Number
    K260842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hardy Diagnostics
    Date Received
    March 16, 2026
    Decision Date
    May 11, 2026
    Product Code
    JTN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTN Susceptibility Test Discs, Antimicrobial

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    Other Clearances by Hardy Diagnostics

    K Number Device Name
    K253105 HardyDisk AST Cefiderocol 30µg (FDC30)
    K250956 HardyDisk AST Gepotidacin 10µg (GEP10)
    K250454 HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
    K233534 Viral Transport Medium
    K241060 HardyDisk AST Cefiderocol 30µg (FDC30)
    K231568 HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
    K230827 HardyDisk AST Rezafungin 5µg (RZF5)
    K193504 HardyDisk AST Cefiderocol 30ug (FDC30)
    K192326 HardyDisk AST Lefamulin 20µg (LMU20)
    K191931 HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
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