# K180068: ORISE Gel

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Sep 28, 2018 after 262 days
- Product code: PLL (Submucosal Injection Agent)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 12 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.

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

## Recalls of this device
- Oct 10, 2022 · Class II · Z-0224-2023: ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure

## Indications for use
This device 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/K180068
Methodology: https://510kreport.com/methodology