# K143669: MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medgyn Products, Inc.
- Decided: Nov 23, 2015 after 334 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: 1 generation back to K954099 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954099: Select Iui, Select Medical Systems, Inc. (1995) Summary page 5.
- K012935: Thecurve, Item 507, Select Medical Systems, Inc. (2001) Summary page 5.

## Indications for use
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.

Source page: https://510kreport.com/device/K143669
Methodology: https://510kreport.com/methodology