# K220007: Pure-Vu EVS System

- Pathway: 510(k) (Special)
- Applicant: Motus GI Medical Technologies, Ltd.
- Decided: Feb 10, 2022 after 37 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: 12 generations back to K921244 (1992). 33 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191220: Pure Vu System, Motus GI Medical Technologies, Ltd. (2019) Summary page 4.

## Most influential descendants
- 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 EVS System is intended to connect to standard and slim 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/K220007
Methodology: https://510kreport.com/methodology