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510(k) Data Aggregation

    K Number
    K062008
    Device Name
    ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2006-08-09

    (23 days)

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

    NITI MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-toside and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.
    Device Description
    The Compression Anastomosis Ring (CAR) device is a sterile single use device. The CAR provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.
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    K Number
    K050356
    Device Name
    COMPRESSION ANASTOMOSIS RING (CAR)
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2005-05-05

    (80 days)

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

    NITI MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.
    Device Description
    The Compression Anastomosis Ring (CAR) device is a sterile single use device. The CAR provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 5-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the ring, detaches and is naturally expelled with the stool.
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    K Number
    K043115
    Device Name
    LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2004-12-01

    (21 days)

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

    NITI MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is wassed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures.
    Device Description
    The Laparoscopic Compression Anastomosis Clip (LapCAC) device is a sterile single patient use device. The LapCAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract in open, minimally invasive and laparoscopic procedures. The LapCAC device is comprised of two components: Clip Reload double ring clip that is inserted into the two cut segments and performs the required compression on the tissue, and Applier/Handle with which the Clip is introduced into the treated area. The LapCAC device has an extended 35 or 45 cm. long shaft and is designed to pass through a 12 mm standard trocar. After a period of 7-10 days, a compression-induced necrosis of the tissue undernouth the was compressed by the rings, detaches and is naturally expelled with the stool.
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    K Number
    K042492
    Device Name
    HAND STC, MODEL 60MM
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2004-10-19

    (35 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    NITI MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.
    Device Description
    The NiTi HandSTC is a palm size linear cutter and stapler whose main parts are housed together enabling one hand operation by sequential pressing on the device lever. The HandSTC applies 56 titanium staples in a line approximately 60mm long. The unformed staples are "U" shape which closed to form "B" shape. When the device is open the distance between the cartridge and the anvil is 4 cm. The HandSTC device is supplied with one cartridge and can be reloaded for a total of 8 firings The reloads are available in two sizes: Blue- unformed staple leg height is 3.5 mm, staple dimension when closed is 1.5 mm. This cartridge closes to a gap of 0.8 mm and it is used for standard tissue and gastrointestinal applications. Green- unformed staple leg height is 4.5 mm, staple dimension when closed is 2.0 mm. This cartridge closes to a gap of 1.3mm and it is used for gastrointestinal tract and thick tissues such as stomach and rectum applications.
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    K Number
    K041751
    Device Name
    COMPRESSION ANASTOMOSIS CLIP (CAC)
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2004-09-16

    (79 days)

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

    NITI MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTi CAC is not applicable through Trocars in laparoscopic procedures.
    Device Description
    The Compression Anastomosis Clip (CAC) device is a sterile single use device. The CAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract. The CAC device is comprised of two components: - Clip double ring clip that is inserted into the two cut segments of the tissue to be anastomosed and performs the required compression on the tissue. - Applier with which the Clip is introduced into the treated area. After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.
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    K Number
    K033324
    Device Name
    COMPRESSION ANASTOMOSIS CLIP (CAC)
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2004-05-10

    (208 days)

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

    NITI MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures.
    Device Description
    The Compression Anastomosis Clip (CAC) device is a sterile single use device. The CAC provides a simple method for the creation of side-to-side compression anastomosis of the intestine. The CAC device is comprised of two components: CLIP - DOUBLE RING CLIP THAT IS INSERTED INTO THE TWO CUT SEGMENTS OF THE INTESTINE AND PERFORMS THE REQUIRED COMPRESSION ON THE TISSUE. APPLIER - WITH WHICH THE CLIP IS INTRODUCED INTO THE TREATED AREA. After a period of 7-10 days, a compression-induced necrosis of the intestine sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.
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