# K172051: Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jan 10, 2018 after 188 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 6.

## Most influential descendants
- K220010: Daylily Single Use Sterile Embryo Transfer Catheter (2022), 0 descendants of its own

## Indications for use
Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Used to place in vitro fertilized (IVF) embryos into the uterine cavity. This device is to be used in combination with a cleared, dimensionally compatible Embryo Transfer Guide Catheter for gaining access to the uterine cavity. Used to supplement and assist uterine access of a cleared, dimensionally compatible Embryo Transfer Catheter for placement of in vitro fertilized (IVF) embryos into the uterine cavity.

Source page: https://510kreport.com/device/K172051
Methodology: https://510kreport.com/methodology