Clearance Summary
ORION'S URINARY DRAINAGE SET received FDA 510(k) clearance under submission number K944377, sponsored by Regulatory & Marketing Services, 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 1994-12-06.
- Submission: K944377
- Applicant / Sponsor: Regulatory & Marketing Services, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1994-12-06
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.