# K191254: EndoClot

- Pathway: 510(k) (Traditional)
- Applicant: Endoclot Plus Co., Ltd.
- Decided: Jan 30, 2020 after 265 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). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 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 4.
- K173601: Merit Syringe, Merit Medical Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- K260997: Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01) (2026), 0 descendants of its own

## Indications for use
EndoClot® Submucosal Injection Agent 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 endoscopic device.

Source page: https://510kreport.com/device/K191254
Methodology: https://510kreport.com/methodology