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510(k) Data Aggregation

    K Number
    K252672

    Validate with FDA (Live)

    Device Name
    CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)
    Manufacturer
    Casebioscience, Inc.
    Date Cleared
    2026-02-20

    (179 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    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
    K252500

    Validate with FDA (Live)

    Device Name
    CARA System
    Manufacturer
    Cara Medical, Ltd.
    Date Cleared
    2026-02-20

    (196 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    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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    K Number
    K252972

    Validate with FDA (Live)

    Device Name
    CARTO™ 3 EP Navigation System V8.4
    Manufacturer
    Biosense Webster, Inc.
    Date Cleared
    2026-02-20

    (156 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Traditional
    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
    K251852

    Validate with FDA (Live)

    Device Name
    cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
    Manufacturer
    VPIX Medical, Inc.
    Date Cleared
    2026-02-13

    (241 days)

    Product Code
    OWN,GCJ,GWG
    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
    K253096

    Validate with FDA (Live)

    Device Name
    Chartis Precision Catheter
    Manufacturer
    Pulmonx Corporation
    Date Cleared
    2026-02-13

    (143 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    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
    K243854

    Validate with FDA (Live)

    Device Name
    Contour Light (CL-100)
    Manufacturer
    Contour Research, LLC
    Date Cleared
    2026-02-13

    (424 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Type
    Special
    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
    K251928

    Validate with FDA (Live)

    Device Name
    CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
    Manufacturer
    Medinice S.A.
    Date Cleared
    2026-02-13

    (235 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    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
    K251813

    Validate with FDA (Live)

    Device Name
    CURIS II RF Generator (REF 360100-05)
    Manufacturer
    Sutter Medizintechnik GmbH
    Date Cleared
    2026-02-11

    (243 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    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
    K253140

    Validate with FDA (Live)

    Device Name
    CollOvine™ Wound Powder
    Manufacturer
    Ovigenex, LLC
    Date Cleared
    2026-02-10

    (138 days)

    Product Code
    KGN
    Regulation Number
    N/A
    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
    K254033

    Validate with FDA (Live)

    Device Name
    Ceribell Instant EEG Headset
    Manufacturer
    Ceribell, Inc.
    Date Cleared
    2026-02-09

    (55 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Abbreviated
    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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