Cleared Special

Disposable Pre-calibrated Brain Biopsy Needle 2.0

K230201 · PAJUNK GmbH Medizintechnologie · Neurology
Feb 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K230201 is an FDA 510(k) clearance for the Disposable Pre-calibrated Brain Biopsy Needle 2.0, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on February 22, 2023, 28 days after receiving the submission on January 25, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K230201 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2023
Decision Date February 22, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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