Cleared Traditional

K992461 - STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K992461 is an FDA 510(k) clearance for STEALTHSTATION TREATMENT GUIDANCE PLATFORM, 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 214-day FDA review.

K992461 · Surgical Navigation Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
214d
Days
Class 2
Risk

K992461 is an FDA 510(k) clearance for the STEALTHSTATION TREATMENT GUIDANCE PLATFORM. 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 February 22, 2000 after a review of 214 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 Surgical Navigation Technologies, Inc. devices

FDA 510(k) Submission Details - K992461

510(k) Number K992461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1999
Decision Date February 22, 2000
Days to Decision 214 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
66d slower than avg
Panel avg: 148d · This submission: 214d
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 K992461.
SELF ADHERING NAVIGUS GUIDE
K001192 · Image-Guided Neurologics, Inc. · Jun 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · Radionics, Inc. · May 2000
SNN STEREOTAXIC PLANNING APPLICATION
K994421 · Surgical Navigation Specialists, Inc. · Feb 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · Stryker Corp. · Jan 2000
BRAINLAB STEREOTACTIC ARC
K992916 · Brainlab · Jan 2000