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510(k) Data Aggregation

    K Number
    K253056

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    Device Name
    Disposable Stone Extraction Basket
    Manufacturer
    Zhejiang Soudon Medical Technology Co., Ltd.
    Date Cleared
    2026-04-03

    (193 days)

    Product Code
    LQR
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K260724

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    Device Name
    MAGENTIQ-COLO (ME-APDS)
    Manufacturer
    Magentiq Eye, Ltd.
    Date Cleared
    2026-04-03

    (29 days)

    Product Code
    QNP
    Regulation Number
    876.1520
    Type
    Special
    Panel
    Gastroenterology/Urology
    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
    K253674

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    Device Name
    Blueprint Patient-Specific Instrumentation
    Manufacturer
    Stryker Corporation (Tornier, S.A.S.)
    Date Cleared
    2026-04-03

    (133 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    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
    DEN240071

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    Device Name
    neuropacs
    Manufacturer
    Automated Imaging Diagnostics, LLC
    Date Cleared
    2026-04-03

    (485 days)

    Product Code
    SHO
    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
    K254153

    Validate with FDA (Live)

    Device Name
    Single-use Video Scope; PB Digital Controller
    Manufacturer
    Mirco-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2026-04-03

    (102 days)

    Product Code
    FBN
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K253340

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    Device Name
    Electric Wheelchair (AL-208S-063)
    Manufacturer
    Zhongshan A&J Medical Equipment Co., Ltd.
    Date Cleared
    2026-04-03

    (185 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    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
    K254060

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    Device Name
    Life Saving Tourniquet
    Manufacturer
    TW Medical
    Date Cleared
    2026-04-03

    (107 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    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
    K260720

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    Device Name
    mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
    Manufacturer
    MED-EL Elektromedizinische Geräte GmbH
    Date Cleared
    2026-04-03

    (29 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Type
    Special
    Panel
    Ear Nose & Throat
    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
    K250074

    Validate with FDA (Live)

    Device Name
    HYALEX® MTP Hemiarthroplasty Implant
    Manufacturer
    Hyalex Orthopaedics, Inc.
    Date Cleared
    2026-04-03

    (448 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Type
    Traditional
    Panel
    Orthopedic
    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
    K253962

    Validate with FDA (Live)

    Device Name
    ClearCheck (RADCC V2.7)
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2026-04-03

    (113 days)

    Product Code
    IYE,MUJ,QKB
    Regulation Number
    892.5050
    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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