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510(k) Data Aggregation

    K Number
    K001915

    Validate with FDA (Live)

    Device Name
    GRAFT MARKER RING
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Date Cleared
    2001-04-27

    (308 days)

    Product Code
    MAB
    Regulation Number
    870.3450
    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
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K002755

    Validate with FDA (Live)

    Device Name
    NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Date Cleared
    2000-12-04

    (90 days)

    Product Code
    LRN
    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
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K954016

    Validate with FDA (Live)

    Device Name
    VIDEOSCOPE W/IRRIGATION SHEATH
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Date Cleared
    1996-01-25

    (153 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    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
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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