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510(k) Data Aggregation

    K Number
    K253363

    Validate with FDA (Live)

    Device Name
    NeuroSpan Bridge
    Manufacturer
    Auxilium Biotechnologies, Inc.
    Date Cleared
    2026-01-17

    (109 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Type
    Traditional
    Panel
    Neurology
    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
    DEN250005

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    Device Name
    Sana Device
    Manufacturer
    Sana Health
    Date Cleared
    2026-01-16

    (319 days)

    Product Code
    QYN
    Regulation Number
    N/A
    Type
    Direct
    Panel
    Neurology
    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
    K252767

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    Device Name
    actiTENS mini
    Manufacturer
    Sublimed
    Date Cleared
    2026-01-16

    (140 days)

    Product Code
    GZJ,IPF,NGX,NUH,NYN
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    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
    K252297

    Validate with FDA (Live)

    Device Name
    Toro 88 Superbore Catheter
    Manufacturer
    Toro Neurovascular, Inc.
    Date Cleared
    2026-01-16

    (177 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    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
    K251357

    Validate with FDA (Live)

    Device Name
    Esperance pHLO Aspiration System
    Manufacturer
    Phenox, Ltd.
    Date Cleared
    2026-01-15

    (260 days)

    Product Code
    NRY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    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
    K252958

    Validate with FDA (Live)

    Device Name
    METICULY Patient-specific titanium mesh implant
    Manufacturer
    Meticuly Co., Ltd.
    Date Cleared
    2026-01-14

    (120 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Type
    Traditional
    Panel
    Neurology
    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
    K252842

    Validate with FDA (Live)

    Device Name
    SafeOp 3: Neural Informatix System
    Manufacturer
    Alphatec Spine, Inc.
    Date Cleared
    2026-01-11

    (125 days)

    Product Code
    GWF
    Regulation Number
    882.1870
    Type
    Traditional
    Panel
    Neurology
    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
    K253308

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    Device Name
    Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
    Manufacturer
    Materialise N.V
    Date Cleared
    2026-01-07

    (100 days)

    Product Code
    PPT
    Regulation Number
    882.4310
    Type
    Special
    Panel
    Neurology
    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
    K251097

    Validate with FDA (Live)

    Device Name
    V-DAC Catheter
    Manufacturer
    Vesalio, Inc.
    Date Cleared
    2026-01-06

    (271 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    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
    K251668

    Validate with FDA (Live)

    Device Name
    SurfRider 13 Microcatheter
    Manufacturer
    Kaneka Americas Holding, Inc.
    Date Cleared
    2026-01-05

    (220 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    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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    Device Description
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