# K160356: Third Eye Panoramic Auxiliary Endoscopy System - Resposable

- Pathway: 510(k) (Traditional)
- Applicant: Avantis Medical Systems, Inc.
- Decided: May 17, 2016 after 99 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 K853585 (1986). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140595: Third Eye Panoramic Auxiliary Endoscopy System, Avantis Medical Systems, Inc. (2014) Summary page 4.

## Indications for use
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System – Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.

Source page: https://510kreport.com/device/K160356
Methodology: https://510kreport.com/methodology