# K230588: Aer-O-Scope Colonoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Gi View, Ltd.
- Decided: Aug 17, 2023 after 168 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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: 8 generations back to K931154 (1993). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 4.

## Most influential descendants
- K261015: Solo Scope Colonoscope System (2026), 0 descendants of its own

## Indications for use
The Aer-O-Scope Colonoscope System is intended to provide visualization (via a video monitor) and diagnostic/therapeutic access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy. The Aer-O-Scope Disposable colonoscope is a single use disposable endoscope and cannot be reprocessed.

Source page: https://510kreport.com/device/K230588
Methodology: https://510kreport.com/methodology