Clearance Summary
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter received FDA 510(k) clearance under submission number K173686, sponsored by Cook Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2018-04-11.
- Submission: K173686
- Applicant / Sponsor: Cook Incorporated
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2018-04-11
Classification & Regulation
This clearance is catalogued under FDA product code MQF and 21 CFR 884.6110, within the Obstetrics/Gynecology review panel as a Class II device.