Clearance Summary
NAVIAID(TM) BGC DEVICE received FDA 510(k) clearance under submission number K111760, sponsored by Smart Medical Systems , Ltd.. 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 2011-08-09.
- Submission: K111760
- Applicant / Sponsor: Smart Medical Systems , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-08-09
Classification & Regulation
This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.