Clearance Summary
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR received FDA 510(k) clearance under submission number K091516, sponsored by Well Lead Medical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-10-16.
- Submission: K091516
- Applicant / Sponsor: Well Lead Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2009-10-16
Classification & Regulation
This clearance is catalogued under FDA product code EZL and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.