# K090217: Bonee Needle for Bladder Injections, MODELSNBI035, NBI070

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Apr 23, 2009 after 84 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: 5 generations back to K820973 (1982). 9 ancestors in all.
2 later devices descend 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)
- K022484: Cook Injection Needle, Cook Urological, Inc. (2002) Summary page 1.

## Most influential descendants
- K192498: Single Use Injector (2020), 1 descendant of its own
- K250522: Multi4 System (2025), 0 descendants of its own

## Indications for use
The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.

Source page: https://510kreport.com/device/K090217
Methodology: https://510kreport.com/methodology