# K222006: Sclerotherapy & Endoscopic Needles

- Pathway: 510(k) (Traditional)
- Applicant: G-Flex Europe Sprl
- Decided: Apr 3, 2023 after 270 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: 3 generations back to K961846 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171454: Interject Injection Therapy Needle Catheter, Boston Scientific Corporation (2017) Summary page 4.

## Indications for use
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.

Source page: https://510kreport.com/device/K222006
Methodology: https://510kreport.com/methodology