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510(k) Data Aggregation

    K Number
    K190168
    Device Name
    Aquas Probes
    Manufacturer
    Genicon, Inc.
    Date Cleared
    2019-03-14

    (42 days)

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

    Genicon, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable a surgeon to manipulate, cut, or coagulate internal tissue or organs while performing laparoscopic procedures.
    Device Description
    The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The probes are insulated for optional monopolar coagulation which enables a surgeon to manipulate, cut, or coagulate soft tissue or organs while performing laparoscopic procedures. The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and tip configurations. Working lengths range from 20 to up to 45 cm. Common tip configurations include L-Hook (Right Angle), J-Hook, Spatula, 45 Deg, Knife, Ball, Needle, and Spoon. Devices may also include a channel for suction and irrigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include retractable insulation and insulation at the digression of the user. Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave.
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    K Number
    K181791
    Device Name
    SIMPLYSTRONG, SIMPLYEZEE
    Manufacturer
    Genicon, Inc
    Date Cleared
    2018-08-21

    (47 days)

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

    Genicon, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE GENICON SIMPLE SPECIMEN RETRIEVAL IS INDICATED FOR USE IN LAPAROSCOPIC PROCEDURES TO CAPTURE ORGANS OR TISSUE TO BE REMOVED FROM THE BODY CAVITY.
    Device Description
    The Genicon Simple Specimen Retrieval Bags are comprised of a flexible plastic bag with and without a deployment mechanism. The deployment mechanism consists of a push rod and handle. The deployment mechanism allows for easy insertion through the cannula to deploy the bag within the body cavity. Bags without a deployment mechanism may be introduced using a standard atraumatic grasper or dissector. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
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    K Number
    K180836
    Device Name
    Genistrong
    Manufacturer
    Genicon, Inc
    Date Cleared
    2018-04-18

    (19 days)

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

    Genicon, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
    Device Description
    The Genicon Specimen Retrieval Bag System is comprised of a flexible plastic bag and deployment mechanism. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
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    K Number
    K180579
    Device Name
    Ezee Retrieval
    Manufacturer
    Genicon, Inc
    Date Cleared
    2018-03-19

    (14 days)

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

    Genicon, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON EZee Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
    Device Description
    The GENICON EZee Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
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    K Number
    K171752
    Device Name
    X-SURGE
    Manufacturer
    Genicon, Inc
    Date Cleared
    2017-10-17

    (126 days)

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

    Genicon, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON X-Surge instrumentation line is intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
    Device Description
    The GENICON X-Surge monopolar laparoscopic instruments are sterile packaged Single Use Mono-Polar attachments intended for use in combination with a compatible reposable handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The device diameter has a range of 3 - 5mm, and connects to a handle with the appropriate configuration. The handle has a male cautery connector that will be utilized for cauterizing soft tissue when attached to standard monopolar cautery cables and their generators. The disposable shaft and tips are composed of an aluminum outer shaft, and a stainless steel drive rod which connects to the scissor blades and interacts with the handle activation rod. The outer insulation consists of fluorinated ethylene which is an insulation with functional material properties that are improved over Polytetrafluoroethylene PTFE, and is less rigid than Radel insulation. The disposable shafts and tips are to be supplied sterile in single unit trays with Tyvek lid, similar to the current GENICON electrosurgical instrumentation line. The Reposable handle is sterilized by the user using an autoclave process and is then connected to the sterile disposable shaft or tip. Once the procedure is completed, the instrument ends are disassembled from the handle, and are disposed of appropriately, and the handle is cleaned and sterilized for the next procedure.
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    K Number
    K162059
    Device Name
    EZEE RETRIEVAL
    Manufacturer
    GENICON, INC
    Date Cleared
    2016-09-29

    (65 days)

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

    GENICON, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON EZEE Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
    Device Description
    The GENICON EZEE Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
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    K Number
    K132375
    Device Name
    GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
    Manufacturer
    GENICON
    Date Cleared
    2014-06-12

    (317 days)

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

    GENICON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
    Device Description
    The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
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    K Number
    K100090
    Device Name
    IMPLANTABLE CLIP
    Manufacturer
    GENICON
    Date Cleared
    2010-02-02

    (21 days)

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

    GENICON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
    Device Description
    The ligation clips are composed exclusively of titanium, and are supplied as sterile products in various sizes (mini-micro, micro, smallmedium, medium, medium-large, large and extra large) with six clips per disposable holder. The titiaum used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".
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    K Number
    K061417
    Device Name
    GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910
    Manufacturer
    GENICON
    Date Cleared
    2006-10-10

    (141 days)

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

    GENICON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoscopic surgical procedures. It is a family of instruments which includes graspers, Linsectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
    Device Description
    The GENICON disposable electrosurgical instruments are single use sterile instruments made from biocompatible plastic and stainless steel with a working length of 33cm. Current may be supplied by an approved electrosurgical generator which provides the ability for the coagulation of tissue when used with an appropriate ground electrode.
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    K Number
    K041967
    Device Name
    GENICON SUCTION IRRIGATION SYSTEM
    Manufacturer
    GENICON
    Date Cleared
    2004-11-12

    (114 days)

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

    GENICON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GeniCon Laparoscopic Suction/Irrigation System is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
    Device Description
    The Genicon Laparoscopic Suction Irrigator system is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, surgical sites and smoke from the surgical site. The system 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 hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigator probe to reach the surgical site. The probes are available in a variety of instruments and diameters. It is a single use, disposable device and is sold sterile, and the probes may be available as single use or reusable depending on the purpose.
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