# K190032: Disposable Sclerotherapy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Feb 27, 2020 after 416 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.
3 later devices descend from it; 2 cite it directly.
0 of 10 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.

## Most influential descendants
- K212668: Sclerotherapy Needle (2022), 1 descendant of its own
- K232826: Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) (2024), 0 descendants of its own
- K232442: Disposable Endoscope Injection Needles (2023), 0 descendants of its own

## Indications for use
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.

Source page: https://510kreport.com/device/K190032
Methodology: https://510kreport.com/methodology