Cleared Traditional

K112469 - GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM

K112469 is an FDA 510(k) clearance for GENERAL PRUPOSE LOCALIZERS AND ADAPTERS..., manufactured by Sonowand AS. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K112469 · Sonowand AS · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
210d
Days
Class 2
Risk

K112469 is an FDA 510(k) clearance for the GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Sonowand AS (Fridley, US). The FDA issued a Cleared decision on March 23, 2012 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 Sonowand AS devices

FDA 510(k) Submission Details - K112469

510(k) Number K112469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2011
Decision Date March 23, 2012
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

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 274
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K112469.
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K122096 · KARL STORZ Endoscopy-America, Inc. · Sep 2012
BRAIN BIOPSY NEEDLE
K112094 · Ad-Tech Medical Instrument Corp · Apr 2012
SURGICASE GUIDE
K111558 · Materialise NV · Mar 2012
IPLAN
K101627 · Brainlab AG · Jun 2011
DISPOSABLE REFLECTIVE MARKER SPHERES
K100038 · Brainlab AG · Jul 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
K092467 · Brainlab AG · May 2010