# K200071: Blue Beacon Submucosal Injectable Solution

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Nov 3, 2020 after 295 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: 7 generations back to K935844 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150852: SIC 8000, Cosmo Technologies, Ltd. (2015) Summary page 5.

## Indications for use
Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

Source page: https://510kreport.com/device/K200071
Methodology: https://510kreport.com/methodology