# K111495: Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jul 19, 2011 after 49 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: 5 generations back to K935844 (1995). 8 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K040961: Injector Needle/Snare, United States Endoscopy Group, Inc. (2004) Summary page 1.
- K083330: Echotip Ultra Ultrasound Needle, Cook Endoscopy (2009) Summary page 1.

## Most influential descendants
- K150852: SIC 8000 (2015), 8 descendants of its own
- K220434: Blue Eye (TS-905) (2022), 1 descendant of its own
- K191923: EverLift Submucosal Lifting Agent (2020), 1 descendant of its own
- K191254: EndoClot (2020), 1 descendant of its own
- K180068: ORISE Gel (2018), 1 descendant of its own

## Indications for use
This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

Source page: https://510kreport.com/device/K111495
Methodology: https://510kreport.com/methodology