# K180552: Modified Novy Cornual Cannulation Set

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jul 12, 2018 after 133 days
- Product code: MOV (Catheters, Salpingography)
- 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 K931476 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931476: Novy Cornual Cannulation Set, Cook Ob/Gyn (1995) Summary page 5.

## Indications for use
The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic or fluoroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation solution or contrast medium, in the evaluation of tubal patency.

Source page: https://510kreport.com/device/K180552
Methodology: https://510kreport.com/methodology