Clearance Summary
ENCIRCLE COMPRESSION THERAPY STOCKING received FDA 510(k) clearance under submission number K122485, sponsored by Encircle Medical Devices , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2013-04-23.
- Submission: K122485
- Applicant / Sponsor: Encircle Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2013-04-23
Classification & Regulation
This clearance is catalogued under FDA product code DWL and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.