# K242668: Gastro Concepts Air Assist

- Pathway: 510(k) (Traditional)
- Applicant: Gastro Concepts, LLC
- Decided: Dec 13, 2024 after 99 days
- Product code: FER (Anoscope And Accessories)
- 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K110792: Gelpoint Path, Applied Medical Resources Corp. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.

Source page: https://510kreport.com/device/K242668
Methodology: https://510kreport.com/methodology