(151 days)
Hypodermic single lumen needle: To inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Piston Syringe: To inject fluids into, or withdraw fluids from the body.
Not Found
This is an FDA 510(k) clearance letter for the "KG Medix Disposable Syringe 1, 3, 5, 10, 20, 30, 50, ML's" and "KG Medix Device Name : SafeOne Disposable Syringe & Needle."
Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets those criteria, as this document is a regulatory clearance letter, not a performance study report. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail specific performance metrics or clinical study results.
Therefore, I cannot provide the requested information.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).