Clearance Summary
QuikClot Control+ received FDA 510(k) clearance under submission number K200167, sponsored by Z-Medica, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2020-04-23.
- Submission: K200167
- Applicant / Sponsor: Z-Medica, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4454
- Decision date: 2020-04-23
Classification & Regulation
This clearance is catalogued under FDA product code POD and 21 CFR 878.4454, within the General, Plastic Surgery review panel as a Class II device.