# K163318: Soules Intrauterine Insemination Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 14, 2017 after 233 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- 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 K842231 (1984). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061679: Wallace Artificial Insemination Catheter, Irvine Scientific Sales Co., Inc. (2006) Summary page 4.

## Indications for use
The Soules Intrauterine Insemination Catheter is used to access the uterine cavity for saline infusion sonohysterography or for the introduction of washed spermatozoa into the uterine cavity.

Source page: https://510kreport.com/device/K163318
Methodology: https://510kreport.com/methodology