# K241591: Blue Eye

- Pathway: 510(k) (Special)
- Applicant: The Standard Co., Ltd.
- Decided: Jul 3, 2024 after 30 days
- Product code: PLL (Submucosal Injection Agent)
- 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: 8 generations back to K935844 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220434: Blue Eye (TS-905), The Standard Co., Ltd. (2022) Summary page 5.

## Indications for use
The Blue Eye is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device.

Source page: https://510kreport.com/device/K241591
Methodology: https://510kreport.com/methodology