Cleared Traditional

ISG VIEWING WAND (K960714) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960714 · I.S.G. Technologies, Inc. · Neurology device
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May 1996
Decision
98d
Days
Class 2
Risk

K960714 is an FDA 510(k) clearance for the ISG VIEWING WAND. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on May 29, 1996 after a review of 98 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 I.S.G. Technologies, Inc. devices

Submission Details

510(k) Number K960714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date May 29, 1996
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
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 105
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K960714.
VIEWPOINT PASSIVE TOOL OPTION
K990868 · Philips Medical Systems (Cleveland), Inc. · Mar 1999
VIEWPOINT - 3.0 SOFTWARE
K970604 · Philips Medical Systems (Cleveland), Inc. · May 1997
OPTICAL DIGITIZER OPTION FOR VIEW POINT
K963221 · Philips Medical Systems (Cleveland), Inc. · Jan 1997
CODMAN FIDUCIAL MARKER SYSTEM
K953568 · Codman & Shurtleff, Inc. · Feb 1996
COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990