Cleared Traditional

K983670 - STEALTHSTATION SYSTEM

K983670 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 87-day FDA review.

K983670 · Surgical Navigation Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
87d
Days
Class 2
Risk

K983670 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 January 14, 1999 after a review of 87 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 - K983670

510(k) Number K983670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date January 14, 1999
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
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 K983670.
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
K990326 · Radionics Software Applications, Inc. · Mar 1999
TRAJECTORY GUIDE, MODEL # TGX-XXX
K983539 · Image-Guided Neurologics, Inc. · Feb 1999
PHILIPS EASYGUIDE
K981480 · Philips Medical Systems, Inc. · Jan 1999
SNN SCOUT
K982570 · I.S.G. Technologies, Inc. · Jan 1999
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
K984245 · Radionics, Inc. · Dec 1998
STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
K983397 · Surgical Navigation Technologies, Inc. · Dec 1998