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510(k) Data Aggregation

    K Number
    K012198
    Device Name
    GIBBONS STERILE TROCAR KITS
    Manufacturer
    GIBBONS SURGICAL CORP.
    Date Cleared
    2001-08-09

    (27 days)

    Product Code
    FBQ
    Regulation Number
    876.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    GIBBONS SURGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.
    Device Description
    Not Found
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    K Number
    K010779
    Device Name
    MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
    Manufacturer
    GIBBONS SURGICAL CORP.
    Date Cleared
    2001-04-10

    (26 days)

    Product Code
    FHO
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GIBBONS SURGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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