Cleared Traditional

K900200 - COOK STEREOTAXIC GUIDE

K900200 is an FDA 510(k) clearance for COOK STEREOTAXIC GUIDE, manufactured by Cook, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K900200 · Cook, Inc. · Neurology device
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May 1990
Decision
135d
Days
Class 2
Risk

K900200 is an FDA 510(k) clearance for the COOK STEREOTAXIC GUIDE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Cook, Inc. (West Lafayette, US). The FDA issued a Cleared decision on May 31, 1990 after a review of 135 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.

FDA 510(k) Submission Details - K900200

510(k) Number K900200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date May 31, 1990
Days to Decision 135 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 149d · This submission: 135d
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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K900200.
BRAINSCAN WORKSTATION
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STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE
K901883 · Stereotactic Image Systems, Inc. · Mar 1991
GNOMOS STEREOTACTIC DEVICE
K901670 · Medical Equipment Development Co., Inc. · Jul 1990
WESTCO MADAYAG PAB NEEDLE
K894387 · Western Medical, Ltd. · Nov 1989
CASS SYSTEM
K894263 · Medical Instrumentation & Diagnostics Corp.(Midco) · Sep 1989
LAITINEN'S TRIGEMINUS STEREOGUIDE
K881132 · Sandstrom Trade & Technology, Inc. · Aug 1988
K900200 · COOK STEREOTAXIC GUIDE
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