Cleared Traditional

Disposable Brain Biopsy Needle 2.0

K220897 · PAJUNK GmbH Medizintechnologie · Neurology
Aug 2022
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K220897 is an FDA 510(k) clearance for the Disposable 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 August 17, 2022, 142 days after receiving the submission on March 28, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K220897 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2022
Decision Date August 17, 2022
Days to Decision 142 days
Submission Type Traditional
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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