(135 days)
YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.
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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, device performance, study design, or specific results of a study as requested in the prompt. The letter confirms that the device, "YI XIN Sterile Syringe For Single Use," is substantially equivalent to predicate devices and can be marketed.
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe 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 male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).