Clearance Summary
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM received FDA 510(k) clearance under submission number K133763, sponsored by Medi-Globe Corporation. 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 2014-05-15.
- Submission: K133763
- Applicant / Sponsor: Medi-Globe Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2014-05-15
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.