Cleared Traditional

K090190 - WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM

K090190 is an FDA 510(k) clearance for WIN-NEUS STEREOTACTIC SURGERY TREATMENT..., manufactured by Nuclemed S.A.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K090190 · Nuclemed S.A. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
256d
Days
Class 2
Risk

K090190 is an FDA 510(k) clearance for the WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Nuclemed S.A. (Hudson, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 256 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.

FDA 510(k) Submission Details - K090190

510(k) Number K090190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2009
Decision Date October 09, 2009
Days to Decision 256 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
107d slower than avg
Panel avg: 149d · This submission: 256d
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 413
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K090190.
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K100314 · Medacta International S.A. · Mar 2010
WAYPOINT STEREOTACTIC SYSTEM
K092192 · FHC, Inc. · Feb 2010
ROSA SURGICAL DEVICE, MODEL ROSA 1.1
K092239 · Medtech S.A · Nov 2009
SONOWAND INVITE
K083597 · Sonowand AS · Sep 2009
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
K092562 · FHC, Inc. · Sep 2009
MONTERIS MEDICAL UFO
K090240 · Monteris Medical, · Aug 2009
K090190 · WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
Download PDF FDA Summary Nuclemed S.A.