Clearance Summary
Saffron Fixation System received FDA 510(k) clearance under submission number K220420, sponsored by Coloplast A/S. 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 2022-06-10.
- Submission: K220420
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2022-06-10
Classification & Regulation
This clearance is catalogued under FDA product code PBQ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.