# K190987: Uroject12 Syringe Lever

- Pathway: 510(k) (Special)
- Applicant: Urogen Pharma, Ltd.
- Decided: Dec 2, 2019 after 231 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: 3 generations back to K820164 (1982). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180345: Uroject12 Syringe Lever, Urogen Pharma, Ltd. (2018) Summary page 4.

## Most influential descendants
- K203321: Cystoject Syringe Lever (2020), 0 descendants of its own

## Indications for use
The Uroject12 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/K190987
Methodology: https://510kreport.com/methodology