Clearance Summary
Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter received FDA 510(k) clearance under submission number K180302, 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 2018-10-24.
- Submission: K180302
- Applicant / Sponsor: Cook Incorporated
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2018-10-24
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.