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510(k) Data Aggregation

    K Number
    K964109
    Device Name
    MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
    Manufacturer
    Date Cleared
    1996-11-27

    (43 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PermaClip™ Cartridge with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.
    Device Description
    The Microsurge Laparoscopic PermaClip™ Cartridge with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The PermaClip ™ cartridge contains up to 12 implantable titanium clips. The closed clip length is approximately 9 mm. The device is designed to be used in conjunction with a separately supplied reusable PermaClip™ Multi-Use Clip Applier to occlude blood vessels and other tubular structures during laparoscopic surgical procedures. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain laparoscopic access. The clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the cartridge to close the cartridge jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the iaws of the cartridge to open and releases the clip from the cartridge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application. The cartridge is sized to fit through a 10 mm cannula. The overall shaft length of the cartridge plus the clip applier handle is approximately 33 mm, consistent with other endoscopic instruments.
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    K Number
    K960554
    Device Name
    DETACHATIP THORACOSCOPIC SCISSORS
    Manufacturer
    Date Cleared
    1996-03-05

    (25 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Microsurge Thoracoscopic Scissors are a line of reusable general surgical scissors intended to be used to cut, dissect and manipulate tissues during general open and thoracoscopic procedures.
    Device Description
    The Microsurge Thoracoscopic Scissors are a modular line of reusable surgical scissors consisting of various size scissors shafts and tips. These integral shafts and tips are essentially identical to the scissors shafts of the Microsurge Detachatip Surgical Instruments and are intended to be used in conjunction with the handles that have been cleared for marketing as part of the Microsurge Detachatip Surgical Instruments. The scissors tips and shafts are sized to fit through 5 mm cannula or directly through intercostal incisions. The shafts range in length from 24 to 43 cm, consistent with other endoscopic instruments such as the Detachatip line manufactured by Microsurge. The shafts are provided either straight or with a prefabricated reverse "S" shaped curve. "The curve provides for increased range of motion when rotating the instrument, thus improving access to internal structures during endoscopic procedures. The shafts are also equipped with a cleaning port to enhance cleaning via direct delivery of cleaning solutions to the lumen of the instruments. The scissors tips are provided in a variety of styles: curved (Metzenbaum), straight, and hook. Each style is suited for specific surgical requirements and tissue types.
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    K Number
    K955408
    Device Name
    MICROSURGE THORACOSCOPIC INSTRUMENTS
    Manufacturer
    Date Cleared
    1996-01-31

    (65 days)

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

    MICROSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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