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510(k) Data Aggregation

    K Number
    K140662
    Device Name
    FLEX ENDOSCOPIC INSTRUMENTS
    Date Cleared
    2014-06-11

    (89 days)

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

    DESIGN STANDARDS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue. The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue. The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue. The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.
    Device Description
    The Flex™ Instruments are endoscopic instruments used for endoscopic minimally invasive surgical procedures to manipulate dissect, and cut tissue. Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. The instrument shafts have a rigid proximal section and flexible steerable distal "end effector" section. The flexible shaft section and end effector tip have a maximum diameter of 4mm. The steerable function provides 5 degrees of freedom. There are seven different instrument types. Four of the instruments are monopolar electrosurgical devices for cutting and coagulation of tissue.
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    K Number
    K040602
    Device Name
    SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
    Date Cleared
    2004-05-10

    (63 days)

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

    DESIGN STANDARDS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sureline™ Laparoscopic Clip Applier with Implantable Titanium clips is intended for use in a variety of laparoscopic procedures to occures to occures and blood vessels. The tissue being ligated should be consistent with the size of the clip.
    Device Description
    The Sureline TM Laparoscopic Clip Applier with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The product is also available as a reusable clip applier and disposable clip cartridge. The disposable clip applier and disposable clip cartridge contain 20 titanium clips. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain a lockrelease moonamamic clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. 13 placed around the clip applier handle/trigger drives a Actuation/oomproom.com/close the cartridge jaws, thereby mechanism within the ourinessel. Release/decompression of forming the clip securely around the jaws of the cartridge to open and the clip applici nandio.ingger all.ge 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 The cartridge is sized to in through andle is approximately 33 mm, consistent with other endoscopic instruments.
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