Clearance Summary
SONOTIP II ULTRASOUND NEEDLE SYSTEM received FDA 510(k) clearance under submission number K051247, sponsored by Medi-Globe 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 2005-06-16.
- Submission: K051247
- Applicant / Sponsor: Medi-Globe Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2005-06-16
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.