Clearance Summary
PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM received FDA 510(k) clearance under submission number K954596, sponsored by Promedical , 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 1995-10-07.
- Submission: K954596
- Applicant / Sponsor: Promedical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1995-10-07
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.