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Cook Stereotaxic Guide

FDA 510(k)

Class II (US FDA 510(k))

510(k) K900200

by Cook, Inc.

Identifiers

510(k) Number
K900200 FDA 510(k)
FDA Product Code
HAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. The Cook Stereotaxic Guide is a specific implementation of this device type, designed for accurate targeting in neurosurgical procedures.

It is supplied as a reusable device intended for use in clinical settings requiring precise neurological instrumentation. The device received FDA 510(k) clearance under K900200 with product code HAW and was determined to be substantially equivalent to a predicate device. It is manufactured by Cook, Inc. and distributed under traditional clearance pathways.

Frequently asked questions

What is the Cook Stereotaxic Guide used for?

The Cook Stereotaxic Guide is a rigid frame with a calibrated guide mechanism designed for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system during neurosurgical procedures.

Is the Cook Stereotaxic Guide a single-use or reusable device?

The Cook Stereotaxic Guide is supplied as a reusable device intended for use in clinical settings requiring precise neurological instrumentation.

What regulatory clearance does the Cook Stereotaxic Guide have?

The Cook Stereotaxic Guide received FDA 510(k) clearance under K900200 with product code HAW and was determined to be substantially equivalent to a predicate device.

Who manufactures the Cook Stereotaxic Guide?

The Cook Stereotaxic Guide is manufactured by Cook, Inc., a company that produces medical devices for various clinical applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: fda.innolitics.com, Wire Guide - Cook Medical, Cook stereotaxic guide - Search Engine for Medical Terms, Abbreviations ..., Wire Guide - Cook Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cook, Inc.

Sources (1)

  • FDA 510(k) K900200 24 fields · synced Sep 24, 2026