# K180302: Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 24, 2018 after 264 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.
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)
- K983594: Embryo Transfer Catheters/Sets, Cook Ob/Gyn (1998) Summary page 4.

## Indications for use
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator: Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity. Guardia™ ETS Embryo-Tested Syringe: For use with catheters indicated for intrauterine insemination and embryo transfer. Flushing Catheter: The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.

Source page: https://510kreport.com/device/K180302
Methodology: https://510kreport.com/methodology