Clearance Summary
INJECTRA INJECTION NEEDLE received FDA 510(k) clearance under submission number K061222, sponsored by Medi-Globe Corp.. 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 2006-07-03.
- Submission: K061222
- Applicant / Sponsor: Medi-Globe Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2006-07-03
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.