# K013501: Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, B

- Pathway: 510(k) (Traditional)
- Applicant: Gynetics Medical Products NV
- Decided: Nov 30, 2001 after 39 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112396: Iui Catheters (2012), 0 descendants of its own

## Indications for use
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa. The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa. The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.

Source page: https://510kreport.com/device/K013501
Methodology: https://510kreport.com/methodology