# K203321: Cystoject Syringe Lever

- Pathway: 510(k) (Special)
- Applicant: Urogen Pharma, Ltd.
- Decided: Dec 9, 2020 after 27 days
- Product code: QBL (Piston Syringe Lever)
- 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: 4 generations back to K820164 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190987: Uroject12 Syringe Lever, Urogen Pharma, Ltd. (2019) Summary page 5.

## Indications for use
The Cystoject Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.

Source page: https://510kreport.com/device/K203321
Methodology: https://510kreport.com/methodology