Cleared Special

K052213 - NAVIGATION SW HIP 3.1 ON CI

K052213 is an FDA 510(k) clearance for NAVIGATION SW HIP 3.1 ON CI, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 79-day FDA review.

K052213 · Brainlab AG · Neurology device
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Nov 2005
Decision
79d
Days
Class 2
Risk

K052213 is an FDA 510(k) clearance for the NAVIGATION SW HIP 3.1 ON CI. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on November 2, 2005 after a review of 79 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 Brainlab AG devices

FDA 510(k) Submission Details - K052213

510(k) Number K052213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2005
Decision Date November 02, 2005
Days to Decision 79 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
69d faster than avg
Panel avg: 148d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

HAW Device Classification - Class 2, Special Controls

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 242
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K052213.
IPLAN
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