# K150852: SIC 8000

- Pathway: 510(k) (Traditional)
- Applicant: Cosmo Technologies, Ltd.
- Decided: Sep 3, 2015 after 156 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: 6 generations back to K935844 (1995). 9 ancestors in all.
8 later devices descend from it; 5 cite 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)
- K111495: Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K, Wilson-Cook Medical, Inc. (2011) Summary page 6.

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

## Indications for use
The SIC 8000 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 other suitable endoscopic device.

Source page: https://510kreport.com/device/K150852
Methodology: https://510kreport.com/methodology