# K983604: Intra-Uterine Transfer, Intra-Folopian Transfer

- Pathway: 510(k) (Traditional)
- Applicant: Washington Regulatory Services
- Decided: May 27, 1999 after 225 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body. Intra-uterine transfer 1) Frydman Catheter 4.5, 5.5 2) Frydman Catheter 4.5 with 2 lumen and removable mandrel 3) Long Frydman Set 4) Frydman Set 5) Soft Frydman Set 6) Soft Frydman Set with madrel 7) TDT Set Intra-fallopian transfer 1) Biset for GIFT 2) Gift Catheter 3) Oliver Set 4) Rinsing Valve for Oliver Set

Source page: https://510kreport.com/device/K983604
Methodology: https://510kreport.com/methodology