# K113050: Clearpath Lower GI

- Pathway: 510(k) (Special)
- Applicant: Easyglide, Ltd.
- Decided: May 16, 2012 after 216 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: 7 generations back to K921244 (1992). 28 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091305: Clearpath, Easyglide, Ltd. (2009) Summary page 1.
- K093779: Clearpath Ugi, Easyglide, Ltd. (2010) Summary page 1.

## Most influential descendants
- K160015: Pure Vu (2016), 7 descendants of its own
- K173392: Pure-Vu System (2017), 6 descendants of its own
- K181437: Pure Vu System (2018), 5 descendants of its own
- K191220: Pure Vu System (2019), 4 descendants of its own
- K220007: Pure-Vu EVS System (2022), 2 descendants of its own

## Indications for use
The ClearPath Lower GI is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

Source page: https://510kreport.com/device/K113050
Methodology: https://510kreport.com/methodology