Cleared Traditional

GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION (K931991) - FDA 510(k) Clearance

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

K931991 · Nomos Corp. · Neurology device
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Aug 1993
Decision
120d
Days
Class 2
Risk

K931991 is an FDA 510(k) clearance for the GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Nomos Corp. (South Miami, US). The FDA issued a Cleared decision on August 20, 1993 after a review of 120 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 Nomos Corp. devices

Submission Details

510(k) Number K931991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date August 20, 1993
Days to Decision 120 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
28d faster than avg
Panel avg: 148d · This submission: 120d
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 103
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K900200 · Cook, Inc. · May 1990