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510(k) Data Aggregation

    K Number
    K200639
    Device Name
    LAP-iX
    Manufacturer
    Sejong Medical Co., Ltd.
    Date Cleared
    2021-09-29

    (568 days)

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

    Sejong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
    Device Description
    The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. They are used during endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required. Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. PISTOL Type has pistol grip handle design. TRUMPET Type has Trumpet grip handle design. The electrode offers three types: L-HOOK, SPOON and J-HOOK Type. All three electrode types are compatible with the PISTOL Type and the TRUMPET Type. The L-Hook & J-Hook electrode tip has a sharp contact surface that facilitates cutting especially for thin and long tissue. The SPOON electrode tip is mainly used for large area tissue and also for hemostasis procedure as well. The voltage should not exceed 175Vrms (300Ω standard), and set to minimum power (100W, 3002 standard). The connector of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode).
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    K Number
    K200638
    Device Name
    LAP-iX Suction Irrigation
    Manufacturer
    Sejong Medical Co., Ltd.
    Date Cleared
    2020-04-03

    (24 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sejong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures.
    Device Description
    The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation). All equipment conforming to this specs can be used. It is provided sterile, for Rx only and single use.
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    K Number
    K173108
    Device Name
    Smoklean
    Manufacturer
    Sejong Medical Co., Ltd.
    Date Cleared
    2018-05-18

    (231 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sejong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.
    Device Description
    During the laparoscopic surgery, the smoke generated by the electrocautery dims the surgeon's vision, affecting the operation and causing the smoke to have a negative effect on the surgeon. It is used in connection with a laparoscopic trocar body or a single port used to expand the surgical site during laparoscopic surgery. This product filters smoke generated when the tissue is cauterized through the laparoscopic trocar body and a single port. The connecting part of the Trocar body or single port is 4.25 * 5.04mm in diameter. The device is consisted of 35cm tubing, a body with filters and an adaptor.
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    K Number
    K173111
    Device Name
    LAP-iX Suction Irrigation
    Manufacturer
    Sejong Medical Co., Ltd.
    Date Cleared
    2017-11-28

    (60 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sejong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAP-iX Suction Irrigation provides suction to a surgical site during laparoscopic and endoscopic procedures.
    Device Description
    The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation).
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    K Number
    K173112
    Device Name
    LAP-iX
    Manufacturer
    Sejong Medical Co., Ltd.
    Date Cleared
    2017-11-21

    (53 days)

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

    Sejong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
    Device Description
    The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required. Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. Each type also offer both Unlock Type and Lock Type. There are 8 models in total. The electrode offers two types: L-HOOK and SPOON Type. The voltage should not exceed 175Vrms (3002 standard), and set to minimum power (100W, 3002 standard). The connector (banana jack) of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode).
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    K Number
    K171726
    Device Name
    LapBag
    Manufacturer
    Sejong Medical Co., Ltd.
    Date Cleared
    2017-09-25

    (105 days)

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

    Sejong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LapBag® is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
    Device Description
    Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.
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    K Number
    K171741
    Device Name
    Laport
    Manufacturer
    Sejong Medical Co., Ltd.
    Date Cleared
    2017-08-29

    (78 days)

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

    Sejong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
    Device Description
    The Laport® Trocars are for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. The Laport® Trocars are consisting of a sleeve and needle in sizes ranging from 5 to 12 mm in diameter. There are three different needles: Safety, Optical and Bladeless Type. The Safety Type has a sharp flat-bladed tip and shield. The shield on the Safety Type needle is designed to cover the flat-bladed tip to protect internal structures from puncture once the abdominal or thoracic cavity has been entered. The Optical Type has a transparent tip for use with an endoscope to provide visualization for insertions. The Bladeless Type has a plastic tip which reduces hazards during puncture of abdominal cavity.
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