# K173392: Pure-Vu System

- Pathway: 510(k) (Special)
- Applicant: Motus GI Medical Technologies, Ltd.
- Decided: Dec 12, 2017 after 43 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: 9 generations back to K921244 (1992). 30 ancestors in all.
6 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)
- K160015: Pure Vu, Motus GI Medical Technologies, Ltd. (2016) Summary page 4.

## Most influential descendants
- 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
- K240853: Pathfinder® CR System (2024), 0 descendants of its own

## Indications for use
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural 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/K173392
Methodology: https://510kreport.com/methodology