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510(k) Data Aggregation

    K Number
    K253327
    Device Name
    HANAROSTENT Esophagus Upper (CCC)
    Manufacturer
    M.I. Tech Co., Ltd.
    Date Cleared
    2025-10-30

    (30 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K253376
    Device Name
    OBSIDIO™ Conformable Embolic (M0013972101010)
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2025-10-30

    (30 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253153
    Device Name
    SER Pen Carain MicroSystem (MP1209SP)
    Manufacturer
    Su-Ko Technologies LLC
    Date Cleared
    2025-10-29

    (33 days)

    Product Code
    QAI
    Regulation Number
    878.4430
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253314
    Device Name
    Freedom Infinia™ Total Knee System
    Manufacturer
    Maxx Orthopedics Inc.
    Date Cleared
    2025-10-29

    (29 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253355
    Device Name
    Difiney Advanced Anti Snoring Device 4.0
    Manufacturer
    Fissiontech LLC
    Date Cleared
    2025-10-29

    (29 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253283
    Device Name
    Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
    Manufacturer
    Shenzhen Root Innovation Technology Co., Ltd.
    Date Cleared
    2025-10-29

    (30 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253242
    Device Name
    LCD Monitor (C1216W, C822W, C821W)
    Manufacturer
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Cleared
    2025-10-29

    (30 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253232
    Device Name
    Seguin Annuloplasty Ring
    Manufacturer
    Abbott Medical
    Date Cleared
    2025-10-29

    (30 days)

    Product Code
    KRH
    Regulation Number
    870.3800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253323
    Device Name
    Protrieve Sheath
    Manufacturer
    Inari Medical
    Date Cleared
    2025-10-29

    (29 days)

    Product Code
    QEW,DYB,KRA
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K253345
    Device Name
    JARVIS Diaphyseal Stem Standard
    Manufacturer
    FH Industrie
    Date Cleared
    2025-10-29

    (29 days)

    Product Code
    PHX,HSD,KWS
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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