Cleared Traditional

K082060 - CRANIAL IMAGE GUIDED SURGERY SYSTEM

K082060 is an FDA 510(k) clearance for CRANIAL IMAGE GUIDED SURGERY SYSTEM, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K082060 · Brainlab AG · Neurology device
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May 2009
Decision
291d
Days
Class 2
Risk

K082060 is an FDA 510(k) clearance for the CRANIAL IMAGE GUIDED SURGERY SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on May 8, 2009 after a review of 291 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

FDA 510(k) Submission Details - K082060

510(k) Number K082060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2008
Decision Date May 08, 2009
Days to Decision 291 days
Submission Type Traditional
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
143d slower than avg
Panel avg: 148d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 337
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K082060.
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K092467 · Brainlab AG · May 2010
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K100314 · Medacta International S.A. · Mar 2010
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K080355 · Elekta Instrument AB · May 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · Smith & Nephew, Inc. · Feb 2009
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K081867 · Mako Surgical Corp. · Nov 2008