Clearance Summary
E-Z-EM ENTEROCLYSIS CATHETER SET received FDA 510(k) clearance under submission number K911349, sponsored by E-Z-Em, Inc.. 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 1992-11-16.
- Submission: K911349
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1992-11-16
Classification & Regulation
This clearance is catalogued under FDA product code EZK and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.