# K210981: Pure Vu System

- Pathway: 510(k) (Special)
- Applicant: Motus GI Medical Technologies, Ltd.
- Decided: Apr 29, 2021 after 28 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.
No later device cites it as a predicate yet.
0 of 34 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.

## Indications for use
Pure-Vu System is intended to connect to standard or slim colonoscopes and gastroscopes to facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating the irrigation fluids (water), bodily fluids and other debris, 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/K210981
Methodology: https://510kreport.com/methodology