Clearance Summary
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER received FDA 510(k) clearance under submission number K031617, sponsored by Mediplus , Ltd.. 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 2004-01-16.
- Submission: K031617
- Applicant / Sponsor: Mediplus , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2004-01-16
Classification & Regulation
This clearance is catalogued under FDA product code KLA and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.