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510(k) Data Aggregation

    K Number
    K142765
    Device Name
    TM SAFETY NEEDLE
    Manufacturer
    ThinkMed Medical Technology Co., Ltd.
    Date Cleared
    2015-08-11

    (320 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    ThinkMed Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TM Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TM Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.
    Device Description
    The TM Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.
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    K Number
    K142767
    Device Name
    ThinkMed Intermittent Catheter with/without Hydrophilic Coating
    Manufacturer
    ThinkMed Medical Technology Co., Ltd.
    Date Cleared
    2015-02-03

    (131 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ThinkMed Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ThinkMed Intermittent Catheter with/without Hydrophilic Coating is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder - voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.
    Device Description
    ThinkMed Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for male and female, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types. The uncoated catheter is manufactured with conventional medical grade, latex-free, biocompatible materials. it is consists of a tubular catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr to 22Fr for Nelaton-tip and sizes 8Fr to 22Fr for Tiemann-tip. The coated catheter is manufactured with conventional medical grade, latex-free, biocompatible materials. Coated with a hydrophilic low-friction coating, with attached a drainage funnel. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water, it becomes slippery and thus reduces friction against the urethra. This allows the coated catheter to slide in and out of the urethra in the most comfortable way. The coated catheter is available in sizes 6Fr to 22Fr for Nelaton-tip and sizes 8Fr to 22Fr for Tiemann-tip.
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