Clearance Summary
WoundExpress received FDA 510(k) clearance under submission number K211200, sponsored by Huntleigh Healthcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-09-03.
- Submission: K211200
- Applicant / Sponsor: Huntleigh Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2021-09-03
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.