Clearance Summary
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR received FDA 510(k) clearance under submission number K063442, sponsored by Degania Silicone , 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 2007-03-26.
- Submission: K063442
- Applicant / Sponsor: Degania Silicone , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2007-03-26
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.