Cleared Traditional

K981686 - STEALTHSTATION SYSTEM DIGITIZER CHANGE

K981686 is the FDA 510(k) clearance for STEALTHSTATION SYSTEM DIGITIZER CHANGE by Surgical Navigation Technologies, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K981686 · Surgical Navigation Technologies, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
86d
Days
Class 2
Risk

K981686 is an FDA 510(k) clearance for the STEALTHSTATION SYSTEM DIGITIZER CHANGE. 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 August 7, 1998 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

Submission Details

510(k) Number K981686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1998
Decision Date August 07, 1998
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.

Device Classification

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 241
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K981686.
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K983603 · Radionics, Inc. · Nov 1998
VECTORVISION SPINE MODULE
K981508 · Brainlab AG · Oct 1998
PHILIPS EASYGUIDE
K980820 · Philips Medical Systems, Inc. · Oct 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981684 · Surgical Navigation Technologies, Inc. · Aug 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · Radionics, Inc. · Aug 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K981213 · Radionics, Inc. · Jul 1998