Clearance Summary
EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER received FDA 510(k) clearance under submission number K041416, sponsored by Deroyal. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2004-07-02.
- Submission: K041416
- Applicant / Sponsor: Deroyal
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2004-07-02
Classification & Regulation
This clearance is catalogued under FDA product code EYC and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.