Clearance Summary
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System received FDA 510(k) clearance under submission number K150891, sponsored by Covidien, LLC( Formerly Beacon Endoscopic Corp.). 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 2015-05-01.
- Submission: K150891
- Applicant / Sponsor: Covidien, LLC( Formerly Beacon Endoscopic Corp.)
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2015-05-01
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.