510(k) K011971

NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 by Image-Guided Neurologics, Inc. — Product Code HAW

K011971 is an FDA 510(k) premarket notification submitted by Image-Guided Neurologics, Inc. for the device "NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000". The FDA issued a decision of Substantially Equivalent on August 3, 2001. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Image-Guided Neurologics, Inc. has at least 10 other 510(k) clearances on record.