Cleared Traditional

K901670 - GNOMOS STEREOTACTIC DEVICE

K901670 is an FDA 510(k) clearance for GNOMOS STEREOTACTIC DEVICE, manufactured by Medical Equipment Development Co., Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K901670 · Medical Equipment Development Co., Inc. · Neurology device
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Jul 1990
Decision
84d
Days
Class 2
Risk

K901670 is an FDA 510(k) clearance for the GNOMOS STEREOTACTIC DEVICE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Medical Equipment Development Co., Inc. (Cinnaminson, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 84 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 Medical Equipment Development Co., Inc. devices

FDA 510(k) Submission Details - K901670

510(k) Number K901670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date July 03, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
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 353
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K901670.
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp. · Mar 1994
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K931991 · Nomos Corp. · Aug 1993
AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
K924348 · Ad-Tech Medical Instrument Corp · Nov 1992
COOK STEREOTAXIC GUIDE
K900200 · Cook, Inc. · May 1990
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · Walter Lorenz Surgical, Inc. · Feb 1988
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K861629 · Downs Surgical , Ltd. · Aug 1986