Clearance Summary
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER received FDA 510(k) clearance under submission number K013704, 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 2002-08-05.
- Submission: K013704
- Applicant / Sponsor: Mediplus , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2002-08-05
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.