Cleared Traditional

K010542 - SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION

K010542 is an FDA 510(k) clearance for SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION, manufactured by Surgical Navigation Specialists, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K010542 · Surgical Navigation Specialists, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
74d
Days
Class 2
Risk

K010542 is an FDA 510(k) clearance for the SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Surgical Navigation Specialists, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on May 8, 2001 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgical Navigation Specialists, Inc. devices

FDA 510(k) Submission Details - K010542

510(k) Number K010542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date May 08, 2001
Days to Decision 74 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
74d faster than avg
Panel avg: 148d · This submission: 74d
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 322
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K010542.
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K011971 · Image-Guided Neurologics, Inc. · Aug 2001
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
K003589 · Brainlab AG · May 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
Z-TOUCH
K003268 · Brainlab AG · Feb 2001