Clearance Summary
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS received FDA 510(k) clearance under submission number K082815, sponsored by Well Lead Medical Instruments. 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 2008-10-08.
- Submission: K082815
- Applicant / Sponsor: Well Lead Medical Instruments
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2008-10-08
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.