# K160217: uVue HSG/SHG Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 6, 2016 after 251 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953034 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123258: The Advance Catheter for HSG and Sis, Catheter Research, Inc. (2013) Summary page 4.

## Most influential descendants
- K180291: Cook Silicone Balloon HSG Catheter (2018), 0 descendants of its own

## Indications for use
The uVue™ HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG) and hysterosalpingography (HSG).

Source page: https://510kreport.com/device/K160217
Methodology: https://510kreport.com/methodology