Clearance Summary
ORS MODEL 6000 ENDOSCOPE HOLDER received FDA 510(k) clearance under submission number K051979, sponsored by O.R. Solutions, Inc.. 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 2005-08-30.
- Submission: K051979
- Applicant / Sponsor: O.R. Solutions, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2005-08-30
Classification & Regulation
This clearance is catalogued under FDA product code OCT and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.