# K160015: Pure Vu

- Pathway: 510(k) (Traditional)
- Applicant: Motus GI Medical Technologies, Ltd.
- Decided: Sep 22, 2016 after 262 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 K921244 (1992). 29 ancestors in all.
7 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)
- K113050: Clearpath Lower GI, Easyglide, Ltd. (2012) Summary page 4.

## Most influential descendants
- 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
- K232922: Pure-Vu EVS System (2023), 1 descendant of its own

## Indications for use
The Pure Vu System 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 doctor offices.

Source page: https://510kreport.com/device/K160015
Methodology: https://510kreport.com/methodology