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510(k) Data Aggregation

    K Number
    K253646

    Validate with FDA (Live)

    Device Name
    Single Use Distal Cover MAJ-2315 (MAJ-2315)
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2026-02-22

    (94 days)

    Product Code
    FDT
    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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    Device Description
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    K Number
    K251692

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    Device Name
    Advanced Tissue Resection Device
    Manufacturer
    Micro-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2026-02-21

    (264 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    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
    K252672

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    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
    K253605

    Validate with FDA (Live)

    Device Name
    Safety Heel Lancet
    Manufacturer
    Ningbo Medsun Medical Co., Ltd.
    Date Cleared
    2026-02-20

    (94 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    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
    K253660

    Validate with FDA (Live)

    Device Name
    KLS Martin Pure Pectus System
    Manufacturer
    KLS-Martin L.P.
    Date Cleared
    2026-02-20

    (92 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
    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
    K253445

    Validate with FDA (Live)

    Device Name
    BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
    Manufacturer
    Bd
    Date Cleared
    2026-02-20

    (141 days)

    Product Code
    FQH
    Regulation Number
    880.5475
    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
    K252989

    Validate with FDA (Live)

    Device Name
    “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
    Manufacturer
    Point Robotics MedTech, Inc.
    Date Cleared
    2026-02-20

    (155 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    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
    K252619

    Validate with FDA (Live)

    Device Name
    QSCHECK UISACR
    Manufacturer
    Qstag, Inc.
    Date Cleared
    2026-02-20

    (185 days)

    Product Code
    JFY,JIR,KQO
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    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
    K251653

    Validate with FDA (Live)

    Device Name
    SPRY TMS Therapy System (0550)
    Manufacturer
    Soterix Medical, Inc.
    Date Cleared
    2026-02-20

    (267 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    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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