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510(k) Data Aggregation

    K Number
    K073671
    Device Name
    PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
    Manufacturer
    NDO SURGICAL, INC.
    Date Cleared
    2008-03-26

    (90 days)

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

    NDO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plicator GSX™ Suturing System is indicated for the endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue.
    Device Description
    The Plicator GSX Suturing System (GSX) deploys a pledgeted, suture to approximate and secure tissue within the gastrointestinal tract. The GSX consists of four procedural components: the Plicator® instrument, the Plicator® tissue retractor, the Plicator® tissue grasper and the Plicator GSX™ suture cartridge. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The grasper is made of surgical grade stainless steel, with a nitinol connecting rod and arms. The pledgeted suture is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The suture is housed in a disposable cartridge. Procedurally, the suture cartridge and either the retractor or the grasper are loaded onto the instrument and the instrument is then passed transorally into the gastrointestinal tract to deploy the suture and secure tissue. Once the Plicator instrument has been introduced transorally, the retractor or grasper is engaged into soft tissue in the gastrointestinal tract and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the suture is deployed, creating a transmural fixation of soft tissue.
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    K Number
    K072125
    Device Name
    ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
    Manufacturer
    NDO SURGICAL, INC.
    Date Cleared
    2007-10-18

    (77 days)

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

    NDO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDO Endoscopic Plication System (EPS) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
    Device Description
    The NDO Surgical Endoscopic Plication System (EPS) deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication. Both the retractor and implant cartridge are provided as sterile, single use, disposable components of the EPS. The Plicator instrument is a non-sterile multiple use device that is subject to cleaning and high level chemical disinfection between uses. To facilitate cleaning and high level disinfection of the Plicator instrument with an Automated Endoscope Reprocessor (AER), the EPS will include a non-procedural "cleaning adapter" accessory.
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    K Number
    K071553
    Device Name
    ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
    Manufacturer
    NDO SURGICAL, INC.
    Date Cleared
    2007-09-18

    (104 days)

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

    NDO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDO Endoscopic Plication System (EPS) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
    Device Description
    The NDO Surgical Endoscopic Plication System (EPS) is a device that deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the Plicator instrument has been introduced into the stomach, the retractor is engaged into the gastric cardia and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating a full thickness, serosa-to-serosa plication.
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    K Number
    K032820
    Device Name
    MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
    Manufacturer
    NDO SURGICAL, INC.
    Date Cleared
    2003-10-23

    (43 days)

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

    NDO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
    Device Description
    The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride coated with parylene. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.
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    K Number
    K031262
    Device Name
    ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
    Manufacturer
    NDO SURGICAL, INC.
    Date Cleared
    2003-05-23

    (32 days)

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

    NDO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
    Device Description
    The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride. The retractor is made of surgical grade stainless steel. with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.
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    K Number
    K023234
    Device Name
    ENDOSCOPIC PLICATION SYSTEM
    Manufacturer
    NDO SURGICAL, INC.
    Date Cleared
    2003-04-17

    (202 days)

    Product Code
    ODE, GAW, KOG
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDO SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to phamacological therapy.
    Device Description
    The Endoscopic Plication System consists of an instrument, retractor, overtube and implant. The instrument is passed transorally to create a plication in close proximity to the gastroesophageal junction. The implant is designed to help pass and secure the suture. The retractor is designed to secure and retract the tissue during the placement of the implant. It is placed down a working channel of the instrument prior to the procedure. The overtube is designed to protect the esophagus during the procedure.
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