# K161791: Aer-O-Scope Colonoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Gi View, Ltd.
- Decided: Aug 11, 2016 after 43 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: 11 generations back to K894632 (1989). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100624: Invendo C20 Colonoscopy System, Invendo Medical Gbmh (2012) Summary page 4.
- K121582: Invendo C25 Colonoscopy System, Invendo Medical Gbmh (2012) Summary page 4.
- K141286: Aer-O-Scope Colonoscope System, Gi View, Ltd. (2014) Summary page 4.

## Indications for use
The Aer-O-Scope Colonoscope System is intended to provide panoramic (360o) 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 Scanner (colonoscope component of the Aer-O-Scope Colonoscope System) is a single use disposable device. An Aer-O-Scope Scanner cannot be reprocessed.

Source page: https://510kreport.com/device/K161791
Methodology: https://510kreport.com/methodology