# K230372: VitreJect Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ocuject, LLC
- Decided: Sep 8, 2023 after 207 days
- Product code: QLY (Ophthalmic Syringe)
- 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
Longest line of descent: 6 generations back to K931367 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200242: StaClear Syringe, Tribofilm Research, Inc. (2020) Summary page 4.

## Indications for use
The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.

Source page: https://510kreport.com/device/K230372
Methodology: https://510kreport.com/methodology