510(k) K011206

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES by Parallax Medical, Inc. — Product Code KNW

K011206 is an FDA 510(k) premarket notification submitted by Parallax Medical, Inc. for the device "PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES". The FDA issued a decision of Substantially Equivalent on July 18, 2001. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Parallax Medical, Inc. has at least 5 other 510(k) clearances on record.