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510(k) Data Aggregation
K Number
K200639Device Name
LAP-iX
Manufacturer
Sejong Medical Co., Ltd.
Date Cleared
2021-09-29
(568 days)
Product Code
GEI
Regulation Number
878.4400Why 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
K200638Device Name
LAP-iX Suction Irrigation
Manufacturer
Sejong Medical Co., Ltd.
Date Cleared
2020-04-03
(24 days)
Product Code
HET
Regulation Number
884.1720Why 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
K173108Device Name
Smoklean
Manufacturer
Sejong Medical Co., Ltd.
Date Cleared
2018-05-18
(231 days)
Product Code
FYD
Regulation Number
878.5070Why 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
K173111Device Name
LAP-iX Suction Irrigation
Manufacturer
Sejong Medical Co., Ltd.
Date Cleared
2017-11-28
(60 days)
Product Code
HET
Regulation Number
884.1720Why 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
K173112Device Name
LAP-iX
Manufacturer
Sejong Medical Co., Ltd.
Date Cleared
2017-11-21
(53 days)
Product Code
GEI
Regulation Number
878.4400Why 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
K171726Device Name
LapBag
Manufacturer
Sejong Medical Co., Ltd.
Date Cleared
2017-09-25
(105 days)
Product Code
GCJ
Regulation Number
876.1500Why 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
K171741Device Name
Laport
Manufacturer
Sejong Medical Co., Ltd.
Date Cleared
2017-08-29
(78 days)
Product Code
GCJ
Regulation Number
876.1500Why 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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