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510(k) Data Aggregation

    K Number
    K123110
    Device Name
    PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    2013-01-17

    (106 days)

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

    SURGICAL INNOVATIONS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate or retract organs and tissues to provide better access as well as visualisation of surgical sites.
    Device Description
    Pretzelflex Surgical Retractor
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    K Number
    K112659
    Device Name
    SURGICAL RETRACTORS
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    2012-03-09

    (178 days)

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

    SURGICAL INNOVATIONS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate organs and tissues to provide better access as well as visualization and stabilization of surgical sites.
    Device Description
    The Surgical Retractor is a Reusable device intended for mobilizing and maneuvering organ and tissue within the cavity during laparoscopic Surgical procedures.
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    K Number
    K111986
    Device Name
    LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    2012-01-26

    (197 days)

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

    SURGICAL INNOVATIONS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.
    Device Description
    Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories
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    K Number
    K100109
    Device Name
    LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    2010-07-15

    (182 days)

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

    SURGICAL INNOVATIONS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.
    Device Description
    The LogiFlex Laparoscopic Band Positioning Device is a sterile, single-use, laparoscopic, blunt dissection instrument. It comprises a shaft with a distal articulating tip incorporating a slot that forms a hook for capturing suture threads and tubing. The LogiFlex Laparoscopic Band Positioning Device is designed to be connected to and used with the reusable, ratchet handle of the Logic Monopolar Laparoscopic Scissors in order to effect articulation of the distal tip. The LogiFlex Laparoscopic Band Positioning Device is not designed to be used with an electrocautery connection.
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    K Number
    K063485
    Device Name
    LOGIC LAPAROSCOPIC SCISSORS
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    2006-12-01

    (14 days)

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

    SURGICAL INNOVATIONS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Innovations Resposable Laparoscopic Scissors are designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular gynaecological and thoracic surgical procedures.
    Device Description
    Surgical Innovations Resposable Laparoscopic Scissors are designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular gynaecological and thoracic surgical procedures. The Logic Resposable Laparoscopic Scissors consist of a reusable handle and disposable insulated shaft with scissor blades. The device has a 5mm diameter disposable insulated shaft that connects to a reusable Polyenylsulfone/stainless steel handle with a male cautery connector to be utilised for monopolar cautery when attached to standard monopolar cautery cables and their generators. The disposable shaft consists of an aluminium outer shaft housing a stainless steel actuation rod, which connects to the scissor blades and handle actuation rod. The disposable shaft is to be supplied sterile in single unit pouches. The scissors will be available in working lengths of 24cm, 32cm and 42cm. The reusable handle is steam sterilized by the user and then connected to the sterile disposable shaft. Following use the shaft and handle are disassembled. The shaft is disposed of and the handle is cleaned and resterilised.
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    K Number
    K955393
    Device Name
    NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    1997-01-09

    (412 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL INNOVATIONS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962193
    Device Name
    PORTLAND TROCARS
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    1996-08-28

    (82 days)

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

    SURGICAL INNOVATIONS PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The PortLand Trocars is very similar to all other trocar devices previously found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976. Due to the increased demand for minimally invasive surgery, trocars have become an essential part of laparoscopic procedures. By providing the surgeon with a fully reusable instrument with replaceable tip such as the PortLand Trocars, SI have optimized the economy of a re-usable instrument, with the advantages of the disposable instrument, in the provision of the replaceable tip concept. The materials used in the construction of the PortLand Trocars are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland. Also, the means of sterilization (autoclaving) has long been used by hospitals for the sterilization of surgical instruments.
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