Clearance Summary
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 received FDA 510(k) clearance under submission number K030854, sponsored by E-Z-Em, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-04-16.
- Submission: K030854
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-04-16
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.