# K173686: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Apr 11, 2018 after 131 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 K983594 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983594: Embryo Transfer Catheters/Sets, Cook Ob/Gyn (1998) Summary page 4.

## Most influential descendants
- K192540: Kitazato ET Catheters (2020), 0 descendants of its own

## Indications for use
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter: Used to place in vitro fertilized (IVF) embryos into the uterine cavity.

Source page: https://510kreport.com/device/K173686
Methodology: https://510kreport.com/methodology