Cleared Traditional

K974161 - STEALTHSTATION SYSTEM

K974161 is an FDA 510(k) clearance for STEALTHSTATION SYSTEM, manufactured by Surgical Navigation Technologies, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K974161 · Surgical Navigation Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
86d
Days
Class 2
Risk

K974161 is an FDA 510(k) clearance for the STEALTHSTATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 21, 1997 after a review of 86 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 Technologies, Inc. devices

FDA 510(k) Submission Details - K974161

510(k) Number K974161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1997
Decision Date November 21, 1997
Days to Decision 86 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 faster than avg
Panel avg: 148d · This submission: 86d
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 355
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K974161.
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
K973684 · Elekta Instrument AB · Mar 1998
LEKSELL STEREOTACTIC SYSTEM
K972324 · Elekta Instrument AB · Mar 1998
STEALTHSTATION SYSTEM
K974187 · Surgical Navigation Technologies, Inc. · Jan 1998
CAROLINE GUIDE/DELIA LOCALIZER
K973277 · Surgical Solutions, Inc. · Nov 1997
STEALTHSTATION PASSIVE INSTRUMENT OPTION
K972398 · Surgical Navigation Technologies, Inc. · Sep 1997
REGULUS NAVIGATOR
K964229 · Compass Intl., Inc. · Aug 1997