# K061222: Injectra Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corp.
- Decided: Jul 3, 2006 after 62 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: 1 generation back to K955558 (1996). 1 ancestor in all.
16 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955558: Gip/Medi-Globe Sclerotherapy Needles, Medi-Globe Corp. (1996) Summary page 1.

## Most influential descendants
- K150434: Injection Needle (2015), 7 descendants of its own
- K132065: Injection Needle (2014), 6 descendants of its own
- K153625: Single Use Injector NM600/610 (2016), 4 descendants of its own
- K210917: Single Use Injection Needle (2021), 3 descendants of its own
- K213914: Injection Needle (2022), 2 descendants of its own

## Indications for use
The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.

Source page: https://510kreport.com/device/K061222
Methodology: https://510kreport.com/methodology