Clearance Summary
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT received FDA 510(k) clearance under submission number K012090, sponsored by Cordis, A Johnson & Johnson Co.. 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 2001-08-01.
- Submission: K012090
- Applicant / Sponsor: Cordis, A Johnson & Johnson Co.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2001-08-01
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.