# K955558: Gip/Medi-Globe Sclerotherapy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corp.
- Decided: Feb 29, 1996 after 85 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
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061222: Injectra Injection Needle (2006), 16 descendants of its own
- 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

Source page: https://510kreport.com/device/K955558
Methodology: https://510kreport.com/methodology