# K083180: Third Eye Retroscope Auxiliary Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Avantis Medical Systems, Inc.
- Decided: Feb 12, 2009 after 107 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: 4 generations back to K853585 (1986). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070330: Third Eye Retroscope Auxiliary Endoscopy System, Avantis Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K091783: Third Eye Retroscope Auxiliary Endoscope System (2009), 4 descendants of its own
- K093187: Modification to Third Eye Retroscope Auxiliary Endoscopy System (2009), 3 descendants of its own
- K140595: Third Eye Panoramic Auxiliary Endoscopy System (2014), 2 descendants of its own
- K180911: Visura Technologies TEECAD System (2018), 0 descendants of its own
- K160356: Third Eye Panoramic Auxiliary Endoscopy System - Resposable (2016), 0 descendants of its own

## Indications for use
The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

Source page: https://510kreport.com/device/K083180
Methodology: https://510kreport.com/methodology