Clearance Summary
RB12 SUCTION RECTAL BIOPSY SYSTEM received FDA 510(k) clearance under submission number K062159, sponsored by Aus Systems Pty , 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 2006-09-05.
- Submission: K062159
- Applicant / Sponsor: Aus Systems Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2006-09-05
Classification & Regulation
This clearance is catalogued under FDA product code FCK and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.