# K261015: Solo Scope Colonoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Gi View, Ltd.
- Decided: Aug 21, 2026 after 147 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: 9 generations back to K931154 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230588: Aer-O-Scope Colonoscope System, Gi View, Ltd. (2023) Summary page 5.

## Indications for use
The Solo 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 Solo Scope Disposable colonoscope is a single use disposable endoscope and cannot be reprocessed.

Source page: https://510kreport.com/device/K261015
Methodology: https://510kreport.com/methodology