Clearance Summary
BMRI SOFT TISSUE BIOPSY NEEDLE received FDA 510(k) clearance under submission number K861959, sponsored by Bio-Medical Resources, 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 1986-09-23.
- Submission: K861959
- Applicant / Sponsor: Bio-Medical Resources, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1986-09-23
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.