Clearance Summary
EchoTip Insight Portosystemic Pressure Gradient Measuring System received FDA 510(k) clearance under submission number DEN180062, sponsored by Cook Ireland, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-11-20.
- Submission: DEN180062
- Applicant / Sponsor: Cook Ireland, Ltd.
- Clearance pathway: Direct
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1050
- Decision date: 2019-11-20
Classification & Regulation
This clearance is catalogued under FDA product code QIJ and 21 CFR 876.1050, within the Gastroenterology, Urology review panel as a Class II device.