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510(k) Data Aggregation

    K Number
    K213010
    Device Name
    FEELject LDV (Low dead volume) syringe
    Manufacturer
    Feeltech Co., Ltd.
    Date Cleared
    2023-05-31

    (618 days)

    Product Code
    QNQ, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Feeltech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FEELject LDV(Low dead volume) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
    Device Description
    A Disposable Syringe with Needle is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a hypodermic single lumen needle which is permanently attached. The device is used to inject fluids into, or withdraw fluids from, the body. It is made of plastic and silicone materials that allows for smooth plunger movement, and manually operated. This is a single-use device. This product is packed by sterile paper and sterilized by E.O gas.
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    K Number
    K172602
    Device Name
    Miracu
    Manufacturer
    Feeltech Co., Ltd.
    Date Cleared
    2018-11-14

    (441 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Feeltech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miracu™ barbed surgical suture is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
    Device Description
    Miracu™ synthetic barded surgical absorbable polydioxanone (PDO) suture with needle is straight, hollow, cannula and is pre-loaded onto the suture. The pigment for the violet dye is D&C Violet No.2. The Miracu™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. Each dyed (violet) suture has bi-directional barbs along axis of the suture monofilament. The Miracu™ Synthetic Absorbable PDO suture with needle approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 4-0, 3-0, and 0, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The Miracu™ is barbed to two sections on suture and the barbs on each section are opposite direction each other.
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