Clearance Summary
K-C HEMOSTATIC BIOPSY SYSTEM received FDA 510(k) clearance under submission number K050135, sponsored by Bioengineering Consultants , 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 2005-07-13.
- Submission: K050135
- Applicant / Sponsor: Bioengineering Consultants , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2005-07-13
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.