# K160846: AmplifEYE

- Pathway: 510(k) (Traditional)
- Applicant: Medivators, Inc.
- Decided: Jul 14, 2016 after 108 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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). 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)
- K122565: Arc Endocuff, Boddingtons Plastics, Ltd. (2012) Summary page 4.
- K151801: Arc Endocuff Vision, Boddingtons Plastics, Ltd. (2015) Summary page 4.

## Indications for use
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: - Keeping the suitable depth of endoscope's view field - Helping the endoscope with being inserted into the gastrointestinal tract

Source page: https://510kreport.com/device/K160846
Methodology: https://510kreport.com/methodology