Clearance Summary
E-Z-EM ENDOSCOPIC CO2 REGULATOR received FDA 510(k) clearance under submission number K053008, sponsored by E-Z-Em, Inc.. 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 2005-12-27.
- Submission: K053008
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2005-12-27
Classification & Regulation
This clearance is catalogued under FDA product code FCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.