# K963364: Glass Van Glass Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Myco Medical Supplies, Inc.
- Decided: May 1, 1998 after 613 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
To be used to administer medication or draw sample. To be used in applications that require clarity that only glass can offer or applications that require smooth plunger movement / control that is not possible with plastic syringe. Also to be used in applications where use of plastic syringe may cause contamination due to reaction of plastic with dispensed substance. May also be used in applications that require stability at extreme temperature.

Source page: https://510kreport.com/device/K963364
Methodology: https://510kreport.com/methodology