Clearance Summary
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 received FDA 510(k) clearance under submission number K090485, sponsored by Percutaneous Systems, Incorporated. 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 2009-07-22.
- Submission: K090485
- Applicant / Sponsor: Percutaneous Systems, Incorporated
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2009-07-22
Classification & Regulation
This clearance is catalogued under FDA product code LQR and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.