# K152035: iSnare system-Lariat

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Oct 15, 2015 after 85 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The US Endoscopy iSnare system - Lariat is intended to be used to inject various types of media and to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures. The device can be used with or without monopolar diathermic energy.

Source page: https://510kreport.com/device/K152035
Methodology: https://510kreport.com/methodology