510(k) K152558

Leksell Stereotactic System, Injection/ Aspiration Needle Kit by Elekta Instrument AB — Product Code HAW

K152558 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "Leksell Stereotactic System, Injection/ Aspiration Needle Kit". The FDA issued a decision of Substantially Equivalent on March 2, 2016. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Elekta Instrument AB has at least 10 other 510(k) clearances on record.