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510(k) Data Aggregation
K Number
K213010Device Name
FEELject LDV (Low dead volume) syringe
Manufacturer
Feeltech Co., Ltd.
Date Cleared
2023-05-31
(618 days)
Product Code
QNQ, FMI
Regulation Number
880.5860Why 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
K172602Device Name
Miracu
Manufacturer
Feeltech Co., Ltd.
Date Cleared
2018-11-14
(441 days)
Product Code
NEW
Regulation Number
878.4840Why 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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