# K171604: Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 15, 2018 after 259 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: 1 generation back to K955508 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955508: Rosch -Thurmond Fallopian Tube Catheterization Set, Cook Urological, Inc. (1996) Summary page 4.

## Most influential descendants
- K181770: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (2019), 0 descendants of its own

## Indications for use
The Rösch Thurmond Fallopian Tube Catheterization Set is intended to be used for through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast medium in the evaluation of tubal patency. The Fallopian Tube Catheterization Set is intended to be used through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast medium in the evaluation of tubal patency. The Fallopian Tube Catheterization Wire Guide with Platinum Tip is to be used through a dimensionally compatible (>0.018 inch inner diameter) uterine access device or selective salpingography catheter to assist in the evaluation of tubal patency.

Source page: https://510kreport.com/device/K171604
Methodology: https://510kreport.com/methodology