Clearance Summary
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES received FDA 510(k) clearance under submission number K011206, sponsored by Parallax Medical, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-07-18.
- Submission: K011206
- Applicant / Sponsor: Parallax Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2001-07-18
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.