Clearance Summary
MILL ROSE ERCP CANNULAS received FDA 510(k) clearance under submission number K941401, sponsored by Mill-Rose Lab, 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 1994-08-17.
- Submission: K941401
- Applicant / Sponsor: Mill-Rose Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-08-17
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.