# K181770: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 29, 2019 after 269 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K171604: Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip, Cook Incorporated (2018) Summary page 4.

## Indications for use
The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency. The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.

Source page: https://510kreport.com/device/K181770
Methodology: https://510kreport.com/methodology