NKN

Syringe, Piston, Reprocessed

Product code

NKN

Device name

Syringe, Piston, Reprocessed

Device class

Class 2

21 CFR

21 CFR 880.5860

Medical specialty

General Hospital

Marketing pathway

510(K)

FDA classification definition

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. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).