Clearance Summary
GIP/MEDI-GLOBE ERCP CATHETERS received FDA 510(k) clearance under submission number K953827, sponsored by Medi-Globe Corp.. 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 1995-09-01.
- Submission: K953827
- Applicant / Sponsor: Medi-Globe Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1995-09-01
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.