Cleared Traditional

K003589 - VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT

K003589 is an FDA 510(k) clearance for VECTORVISION CRANIAL, 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 182-day FDA review.

K003589 · Brainlab AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
182d
Days
Class 2
Risk

K003589 is an FDA 510(k) clearance for the VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT. 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 May 21, 2001 after a review of 182 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 - K003589

510(k) Number K003589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date May 21, 2001
Days to Decision 182 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
34d slower than avg
Panel avg: 148d · This submission: 182d
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 333
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K003589.
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K010204 · Stryker Corp. · Aug 2001
VECTORVISION CT/FLUORO
K010968 · Brainlab AG · Aug 2001
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K011971 · Image-Guided Neurologics, Inc. · Aug 2001
STEREOTACTIC FRAME BASED SYSTEM
K003486 · Stryker Instruments · May 2001
LORENZ FIDUCAIL SCREW
K010427 · Walter Lorenz Surgical, Inc. · Mar 2001
ORTHOPILOT
K003347 · Kinamed, Inc. · Feb 2001