Clearance Summary
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE received FDA 510(k) clearance under submission number K011591, sponsored by Wilson-Cook Medical, Inc.. 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 2002-07-19.
- Submission: K011591
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3610
- Decision date: 2002-07-19
Classification & Regulation
This clearance is catalogued under FDA product code ESW and 21 CFR 878.3610, within the General, Plastic Surgery review panel as a Class II device.