# K971664: Ramy Piston Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Alshifa Medical Syringes Mfg. Co., Ltd.
- Decided: Jul 25, 1997 after 80 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
General purpose single use piston syringe used to withdraw or inject fluids into the body. The device is sold as sterile with attached needle and is non-pyrogenic. The device is not intended for use with any specific drugs or biologics. It is sold as a prescription device with needle attached and ready for use.

Source page: https://510kreport.com/device/K971664
Methodology: https://510kreport.com/methodology