# K192498: Single Use Injector

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Apr 28, 2020 after 230 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K820973 (1982). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090217: Bonee Needle for Bladder Injections, MODELSNBI035, NBI070, Coloplast A/S (2009) Summary page 4.

## Most influential descendants
- K250522: Multi4 System (2025), 0 descendants of its own

## Indications for use
This instrument has been designed to be used with an Olympus endoscope to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.

Source page: https://510kreport.com/device/K192498
Methodology: https://510kreport.com/methodology