Clearance Summary
CYBERREN received FDA 510(k) clearance under submission number K970989, sponsored by Cybernius Medical , Ltd.. 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 1997-07-24.
- Submission: K970989
- Applicant / Sponsor: Cybernius Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1997-07-24
Classification & Regulation
This clearance is catalogued under FDA product code KPF and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.