Clearance Summary
BNX FINE NEEDLE ASPIRATION SYSTEM received FDA 510(k) clearance under submission number K103668, sponsored by Boston Endoscopic Engineering. 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 2010-12-30.
- Submission: K103668
- Applicant / Sponsor: Boston Endoscopic Engineering
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2010-12-30
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.