Clearance Summary
MARK II/MARK III MANOMETRIC PERFUSION PUMP received FDA 510(k) clearance under submission number K013154, sponsored by Dentsleeve Pty., Ltd.. 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 2001-10-19.
- Submission: K013154
- Applicant / Sponsor: Dentsleeve Pty., Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2001-10-19
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.