# K161547: Transem and EchoGen Embryo Transfer Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Mar 9, 2017 after 279 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: 2 generations back to K983594 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033084: Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter, Portex, Ltd. (2003) Summary page 4.

## Indications for use
The Transem and EchoGen™ are catheters with angled or spherical tips for embryo transfer into the uterine cavity in the treatment of infertility. The Transem Stylets are intended to assist the insertion of the Transem or EchoGen™ catheters where the passage through the cervix is impeded.

Source page: https://510kreport.com/device/K161547
Methodology: https://510kreport.com/methodology