# K180291: Cook Silicone Balloon HSG Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 26, 2018 after 267 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: 5 generations back to K953034 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160217: uVue HSG/SHG Catheter, Cook Incorporated (2016) Summary page 4.

## Indications for use
The Cook® Silicone Balloon HSG Catheter is used for delivery of contrast medium or saline into the uterine cavity and fallopian tubes for the evaluation of tubal patency using hysterosalpingography, or to access the uterine cavity for saline infusion sonohysterography.

Source page: https://510kreport.com/device/K180291
Methodology: https://510kreport.com/methodology