Clearance Summary
SONOTIP II ULTRASOUND NEEDLE SYSTEM received FDA 510(k) clearance under submission number K070129, 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 2007-01-31.
- Submission: K070129
- Applicant / Sponsor: Medi-Globe Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2007-01-31
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.