Cleared Traditional

K082060 - CRANIAL IMAGE GUIDED SURGERY SYSTEM

K082060 is the FDA 510(k) clearance for CRANIAL IMAGE GUIDED SURGERY SYSTEM by Brainlab AG. It is a Class 2 Neurology device (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

Submission Details

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.

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 225
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K082060.
DISPOSABLE REFLECTIVE MARKER SPHERES
K100038 · Brainlab AG · Jul 2010
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K092467 · Brainlab AG · May 2010
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K100314 · Medacta International S.A. · Mar 2010
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
K080355 · Elekta Instrument AB · May 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · Smith & Nephew, Inc. · Feb 2009
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
K081867 · Mako Surgical Corp. · Nov 2008