Clearance Summary
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 received FDA 510(k) clearance under submission number K022023, sponsored by Clinical Innovations, Inc.. 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 2003-01-07.
- Submission: K022023
- Applicant / Sponsor: Clinical Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2003-01-07
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.