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510(k) Data Aggregation

    K Number
    K250917
    Device Name
    Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
    Manufacturer
    Shenzhen Sanping Image Technology Co., Ltd.
    Date Cleared
    2025-10-31

    (218 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252427
    Device Name
    Diode Laser Hair Removal Machine (GLD01)
    Manufacturer
    Sanhe Meditech Co.,Ltd
    Date Cleared
    2025-10-31

    (91 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    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
    K250358
    Device Name
    BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2025-10-31

    (266 days)

    Product Code
    PCI,OOI,PCH
    Regulation Number
    866.3990
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251547
    Device Name
    DESS Dental Smart Solutions
    Manufacturer
    Terrats Medical SL
    Date Cleared
    2025-10-31

    (163 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    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
    K252412
    Device Name
    Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
    Manufacturer
    Applied Medical Resources Corporation
    Date Cleared
    2025-10-31

    (91 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    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
    K251041
    Device Name
    GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
    Manufacturer
    Actuated Medical, Inc.
    Date Cleared
    2025-10-31

    (211 days)

    Product Code
    FDS
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252088
    Device Name
    Firebird SI Navigation System
    Manufacturer
    Orthofix US LLC
    Date Cleared
    2025-10-31

    (121 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    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
    K250338
    Device Name
    MSS - Humeral reverse liners extension
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2025-10-31

    (267 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    Type
    Traditional
    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
    K252074
    Device Name
    Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
    Manufacturer
    Canon Medical Systems Corporation
    Date Cleared
    2025-10-31

    (121 days)

    Product Code
    IYN,ITX,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    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
    K252777
    Device Name
    Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
    Manufacturer
    Maxx Orthopedics, Inc.
    Date Cleared
    2025-10-31

    (59 days)

    Product Code
    MBH
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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