Cleared Special

K230201 - Disposable Pre-calibrated Brain Biopsy ...

K230201 is the FDA 510(k) clearance for Disposable Pre-calibrated Brain Biopsy ... by PAJUNK GmbH Medizintechnologie. It is a Class 2 Neurology device (product code HAW) cleared through the Special 510(k) pathway after a 28-day FDA review.

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

K230201 is an FDA 510(k) clearance for the Disposable Pre-calibrated Brain Biopsy Needle 2.0. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on February 22, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all PAJUNK GmbH Medizintechnologie devices

Submission Details

510(k) Number K230201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 217
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