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510(k) Data Aggregation

    K Number
    K250059
    Device Name
    BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2025-09-12

    (245 days)

    Product Code
    ONB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General Hospital

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251843
    Device Name
    Erchonia EVRL
    Manufacturer
    Erchonia Corporation
    Date Cleared
    2025-09-12

    (88 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General & Plastic Surgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252189
    Device Name
    LED Light Therapy Mask (2311, 2344, 2457, 2458)
    Manufacturer
    Dongguan Yanxi Technology Co., Ltd.
    Date Cleared
    2025-09-12

    (60 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General & Plastic Surgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252225
    Device Name
    PowerKnot High Strength Sutures
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2025-09-12

    (58 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General & Plastic Surgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251826
    Device Name
    RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
    Manufacturer
    Smith & Nephew Medical Ltd
    Date Cleared
    2025-09-11

    (90 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General & Plastic Surgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250734
    Device Name
    OptiLUV Device
    Manufacturer
    Pollogen Ltd.
    Date Cleared
    2025-09-10

    (183 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General & Plastic Surgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251817
    Device Name
    da Vinci SP Surgical System (SP1098)
    Manufacturer
    Intuitive Surgical Inc.
    Date Cleared
    2025-09-10

    (89 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General & Plastic Surgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251227
    Device Name
    da Vinci Surgical System (IS5000)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2025-09-08

    (140 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General & Plastic Surgery

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252478
    Device Name
    Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port
    Manufacturer
    Bard Access Systems, Inc.
    Date Cleared
    2025-09-05

    (29 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General Hospital

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K244038
    Device Name
    High Pressure Tubing
    Manufacturer
    Shandong INT Medical Instruments Co., Ltd.
    Date Cleared
    2025-09-05

    (249 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    General Hospital

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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