# K260997: Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)

- Pathway: 510(k) (Traditional)
- Applicant: Endoclot Plus Co., Ltd.
- Decided: Sep 9, 2026 after 167 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180068: ORISE Gel, Boston Scientific (2018) Summary page 5.
- K191254: EndoClot, Endoclot Plus Co., Ltd. (2020) Summary page 5.

## Indications for use
SIS BLU is intended 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 other endoscopic device.

Source page: https://510kreport.com/device/K260997
Methodology: https://510kreport.com/methodology