# K260262: Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Mirco-Tech (Nanjing) Co., Ltd.
- Decided: May 29, 2026 after 121 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 K955558 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150434: Injection Needle, Micro-Tech (Nanjing) Co., Ltd. (2015) Summary page 5.

## Indications for use
The injection needle is intended for use in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the Gl tract.

Source page: https://510kreport.com/device/K260262
Methodology: https://510kreport.com/methodology