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510(k) Data Aggregation

    K Number
    K253536

    Validate with FDA (Live)

    Device Name
    Evala Nerve Stimulator (EPNR002)
    Manufacturer
    Epineuron Technologies, Inc.
    Date Cleared
    2026-02-27

    (106 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254249

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    Device Name
    HKT Anatomical Locking Trauma System
    Manufacturer
    Hankil Tech Medical Co., Ltd.
    Date Cleared
    2026-02-27

    (60 days)

    Product Code
    HRS,HTN,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260292

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    Device Name
    HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
    Manufacturer
    Atraverse Medical
    Date Cleared
    2026-02-27

    (29 days)

    Product Code
    DXF
    Regulation Number
    870.5175
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253829

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    Device Name
    Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
    Manufacturer
    Beijing HuaCheng Taike Technology Co., Ltd.
    Date Cleared
    2026-02-27

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252448

    Validate with FDA (Live)

    Device Name
    AViTA Pulse Oximeter (SP61)
    Manufacturer
    Avita Corporation
    Date Cleared
    2026-02-27

    (207 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253695

    Validate with FDA (Live)

    Device Name
    LigaMend
    Manufacturer
    Riverpoint Medical, LLC
    Date Cleared
    2026-02-27

    (98 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253797

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    Device Name
    One-Stop
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2026-02-27

    (91 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252714

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    Device Name
    C-Lant Port
    Manufacturer
    Vigor Medical Technologies , Ltd.
    Date Cleared
    2026-02-27

    (184 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251998

    Validate with FDA (Live)

    Device Name
    Atellica CH Diazo Total Bilirubin (D_TBil)
    Manufacturer
    Siemens Healthcare Diagnostics, Inc.
    Date Cleared
    2026-02-27

    (245 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253535

    Validate with FDA (Live)

    Device Name
    Ligence Heart
    Manufacturer
    Ligence Uab
    Date Cleared
    2026-02-27

    (106 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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