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510(k) Data Aggregation

    K Number
    K141594
    Device Name
    Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
    Manufacturer
    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
    Date Cleared
    2015-08-10

    (423 days)

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

    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimicro Trocar kit,Model: Auto-Locking Trocar, and Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
    Device Description
    The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal ,a valve,and a stopcock.This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The Hasson Trocar has application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The Hasson Trocar is available in two (2) sizes: 10mm and 12mm.This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock. The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
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    K Number
    K142208
    Device Name
    Monopolar Laparascopic Accessories
    Manufacturer
    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
    Date Cleared
    2015-04-13

    (245 days)

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

    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Monopolar Laparoscopic Accessories is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.
    Device Description
    The Monopolar Laparoscopic Accessories includes Grasping Forceps, Monopolar Scissors, and Monopolar Probe/Electrodes. The devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.
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    K Number
    K141593
    Device Name
    UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
    Manufacturer
    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
    Date Cleared
    2014-11-13

    (153 days)

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

    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimicro Disposable Retrieval Endo-Pouch is intended for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
    Device Description
    The Unimicro Disposable Retrieval Endo-Pouch is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimicro Disposable Retrieval Endo-Pouch is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.
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    K Number
    K141592
    Device Name
    UNIMICRO SUCTION IRRIATION TUBING SET
    Manufacturer
    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
    Date Cleared
    2014-08-04

    (52 days)

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

    UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimicro Suction Irrigation Tubing set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic, 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 Unimicro Suction Irrigation Tubing set 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, tissue debris, and smoke from the surgical site. The suction irrigation set 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 irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
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