Cleared Traditional

K070556 - BRAINSUITE NET

K070556 is the FDA 510(k) clearance for BRAINSUITE NET by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K070556 · Brainlab AG · Neurology device
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Sep 2007
Decision
210d
Days
Class 2
Risk

K070556 is an FDA 510(k) clearance for the BRAINSUITE NET. 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 September 25, 2007 after a review of 210 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 K070556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2007
Decision Date September 25, 2007
Days to Decision 210 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
62d slower than avg
Panel avg: 148d · This submission: 210d
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 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K070556.
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
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VECTOR VISION HIP
K072716 · Brainlab AG · Oct 2007
VECTORVISION HIP AND HIP SR
K072573 · Brainlab AG · Oct 2007
DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071334 · DePuy Orthopaedics, Inc. · Jul 2007
DEPUY CI HIP INSTRUMENTATION
K071135 · DePuy Orthopaedics, Inc. · May 2007
VV FLUORO 3D
K070106 · Brainlab AG · Apr 2007