Clearance Summary
ORION ALL SILICONE FOLEY CATHETER received FDA 510(k) clearance under submission number K944382, 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: K944382
- Applicant / Sponsor: Regulatory & Marketing Services, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1994-12-06
Classification & Regulation
This clearance is catalogued under FDA product code EZL and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.