Clearance Summary
RADIANCE ULTRA 32 4K ZEROWIRE DUO received FDA 510(k) clearance under submission number K222890, sponsored by Nds Surgical Imaging, LLC. 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 2022-10-19.
- Submission: K222890
- Applicant / Sponsor: Nds Surgical Imaging, LLC
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2022-10-19
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.