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510(k) Data Aggregation

    K Number
    K223593
    Device Name
    Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
    Manufacturer
    Taiwan Surgical Corporation
    Date Cleared
    2023-03-22

    (111 days)

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

    Taiwan Surgical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Inno-Port Disposable Bladeless Trocars are in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The Inno-Port Disposable Optical Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
    Device Description
    The Inno-Port Disposable Bladeless Trocar and Inno-Port Disposable Optical Trocar are surgical trocars available in 5 mm, 5-11 mm, and 5-12 mm series. They consist of an obturator and a cannula with a self-adjusting seal and stopcock valve. The optical trocar obturator also contains a scope retention mechanism. The seal system accommodates instruments ranging from 5mm to 12mm in diameter depending on the trocar size.
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    K Number
    K202994
    Device Name
    InnoClip Disposable Clip Applier, InnoClip Clip Applier
    Manufacturer
    Taiwan Surgical Corporation
    Date Cleared
    2022-01-04

    (460 days)

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

    Taiwan Surgical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking. The InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.
    Device Description
    InnoClip™ Disposable Clip Applier consists of a molded handle and trigger, a 360° rotational knob, a cartridge housing shaft and a pair of jaws which is easy for surgeon to hold the operation field in the natural position. This device includes models DC5T1-BX and DC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves. InnoClip™ Disposable Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Disposable Clip Applier enables the surgeon to apply a maximum number of 10 clips for DC5T1-BX or 16 clips for DC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The pre-loaded clips in the shaft are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger. InnoClip™ Clip Applier has two parts, Reusable Handle and a Disposable Clip Cartridge. The Reusable Handle consists of a molded handle, trigger, openable cover and a 360° rotational knob. The Disposable Clip Cartridge consists of a cartridge housing shaft and a pair of jaws which provide secured of the clip to the targeted vessel. The Disposable Clip Cartridge and the Reusable Handle can be easily assembled together by inserting the Disposable Clip Cartridge through a slot located in the Reusable Handle. This device includes models RC5T1-BX and RC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves. InnoClip™ Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Clip Applier enables the surgeon to apply a maximum number of 10 clips for RC5T1-BX or 16 clips for RC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The reusable handle design also reduces the surgical cost and waste. The pre-loaded clips in the Disposable Clip Cartridge are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.
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    K Number
    K150259
    Device Name
    CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
    Manufacturer
    TAIWAN SURGICAL CORPORATION
    Date Cleared
    2015-11-06

    (276 days)

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

    TAIWAN SURGICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.
    Device Description
    The Clip Applier consists of a handle piece and implantable titanium clips. The Clip Applier handle piece consists of a molded handle and trigger, a 360 degrees rotational knob, a cartridge housing shaft and a pair of jaws which provide secured placement of the clip to the desired vessel. The design enables the surgeon to apply several clips during a laparoscopic procedure without the need for withdrawing and reinserting the Clip Applier each time a clip is put in place and closed. The Clip Applier is designed to be used with a black loaded, sterile cartridge supplied in a sterile pouch. The single use disposable clip cartridge sits inside the shaft of the Clip Applier handle piece. While fully squeezing the hand piece trigger, the cartridge is inserted into the shaft through a slot located in the instrument rear.
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    K Number
    K150253
    Device Name
    Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
    Manufacturer
    TAIWAN SURGICAL CORPORATION
    Date Cleared
    2015-04-01

    (57 days)

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

    TAIWAN SURGICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Suction Irrigation is indicated for general purpose use as suction/irrigation device to facilitate lavage during laparoscopic surgery and general surgery. The device functions to aid flushing blood and tissue debris from the surgical site.
    Device Description
    The suction irrigation set, consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure. The suction irrigation set is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood. tissue debris, and smoke from the surgical site while the hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
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