# K050521: Embryo Transfer Catheter with Accessory Stylet, Models 9018, 9023, 9018-S, 9023-S

- Pathway: 510(k) (Abbreviated)
- Applicant: Inntec, Inc.
- Decided: May 2, 2005 after 62 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 K992307 (1999). 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)
- K992307: Embryo Glide Embryo Transfer Catheter, Embryo Glide Style for Embryo Transfer Catheter, Fertility Technology Resources, Inc. (1999) Summary page 1.

## Indications for use
The InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

Source page: https://510kreport.com/device/K050521
Methodology: https://510kreport.com/methodology