# K112698: Concentric Balloon Google

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: May 18, 2012 after 245 days
- Product code: ODC (Endoscope Channel Accessory)
- 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 intended use of the Balloon Goggle is to help the endoscope with being inserted into the gastrointestinal tract with or without the aid of gas (air or CO2) insufflation.

Source page: https://510kreport.com/device/K112698
Methodology: https://510kreport.com/methodology