510(k) K230201

Disposable Pre-calibrated Brain Biopsy Needle 2.0 by PAJUNK GmbH Medizintechnologie — Product Code HAW

K230201 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "Disposable Pre-calibrated Brain Biopsy Needle 2.0". The FDA issued a decision of Substantially Equivalent on February 22, 2023. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.