# K171673: Focus Cap

- Pathway: 510(k) (Traditional)
- Applicant: Gce Medical Corporation
- Decided: Jan 19, 2018 after 227 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: 3 generations back to K853585 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597, Olympus America, Inc. (1999) Summary page 4.

## Indications for use
The Focus Cap has been designed to be attached to the distal end of a colonoscope. The Focus Cap is intended for the following: * For use in keeping the suitable depth of the colonoscope's field of view.

Source page: https://510kreport.com/device/K171673
Methodology: https://510kreport.com/methodology