Cleared Traditional

K965139 - SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM

K965139 is an FDA 510(k) clearance for SURGICAL MICROSCOPE NAVIGATOR (SMN) SYS..., manufactured by Carl Zeiss, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K965139 · Carl Zeiss, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
121d
Days
Class 2
Risk

K965139 is an FDA 510(k) clearance for the SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 121 days - within the typical 510(k) review window.

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 Carl Zeiss, Inc. devices

FDA 510(k) Submission Details - K965139

510(k) Number K965139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date April 23, 1997
Days to Decision 121 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
27d faster than avg
Panel avg: 148d · This submission: 121d
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 K965139.
VECTORVISION
K962939 · Brainlab, Inc. · May 1997
VIEWPOINT - 3.0 SOFTWARE
K970604 · Philips Medical Systems (Cleveland), Inc. · May 1997
NEUROMATE STEREOTACTIC SYSTEM
K963256 · Integrated Surgical Systems, S.A. · May 1997
OPTICAL DIGITIZER OPTION FOR VIEW POINT
K963221 · Philips Medical Systems (Cleveland), Inc. · Jan 1997
PHILIPS EASYGUIDE NEURO
K961834 · Philips Medical Systems, Inc. · Nov 1996
STEALTHSTATION SYSTEM
K963173 · Surgical Navigation Technologies, Inc. · Oct 1996