510(k) K192945

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application by 7D Surgical, Inc. — Product Code HAW

K192945 is an FDA 510(k) premarket notification submitted by 7D Surgical, Inc. for the device "7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application". The FDA issued a decision of Substantially Equivalent on Nov 27, 2019. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. 7D Surgical, Inc. has 9 other 510(k) clearances on record.