Clearance Summary
SUREcore Prime Biopsy Instrument received FDA 510(k) clearance under submission number K230646, sponsored by Uro-1 Medical, Inc.. 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 2023-11-29.
- Submission: K230646
- Applicant / Sponsor: Uro-1 Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2023-11-29
Classification & Regulation
This clearance is catalogued under FDA product code KNW and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.