Clearance Summary
INJECTION NEEDLE PROBE/DEVICE-TUNIS received FDA 510(k) clearance under submission number K983765, sponsored by Ximed/Prosure/Injectx. 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 1998-12-11.
- Submission: K983765
- Applicant / Sponsor: Ximed/Prosure/Injectx
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1998-12-11
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.