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Compass CT Stereotactic Adaptation System

by Stereotactic Medical Systems, Inc.

510(k) K862220

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862220 Date18 Jun 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Compass CT Stereotactic Adaptation System is a Neurological Stereotaxic Instrument designed to interface with computed tomography (CT) imaging systems for precise stereotactic neurosurgical procedures. It enables accurate spatial localization and targeting within the brain, facilitating interventions such as biopsies, catheter placements, or tumor resections by aligning physical coordinates with radiographic imaging.

This system is supplied as a reusable medical device and is intended for use in sterile operating room environments. It is classified under FDA product code HAW and was granted 510(k) clearance (K862220) in 1986, with a decision of Substantially Equivalent (SESE) by the Neurology (NE) advisory committee. No specific MRI safety information is provided, and its use requires adherence to standard surgical protocols for neurosurgical applications.

Other devices from Stereotactic Medical Systems, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Compass CT Stereotactic Adaptation System used for?

    The Compass CT Stereotactic Adaptation System is designed to interface with CT imaging systems during neurosurgical procedures. It provides precise spatial localization and targeting within the brain, allowing clinicians to perform interventions such as biopsies, catheter placements, or tumor resections with accuracy by aligning physical coordinates with radiographic imaging.

  • Is the Compass CT Stereotactic Adaptation System reusable or single-use?

    The system is supplied as a reusable medical device. It is intended for use in sterile operating room environments, requiring proper cleaning and sterilization between procedures to maintain safety and functionality.

  • What type of imaging does the Compass CT Stereotactic Adaptation System work with?

    This system is specifically designed to interface with computed tomography (CT) imaging systems. It enables stereotactic neurosurgical procedures by combining physical instrumentation with CT-generated radiographic images for precise targeting.

  • Does the Compass CT Stereotactic Adaptation System have any MRI safety information?

    No specific MRI safety information is provided for the Compass CT Stereotactic Adaptation System. Its use is limited to CT-guided procedures, and standard neurosurgical protocols must be followed to ensure patient safety.

  • What regulatory pathway was followed for the Compass CT Stereotactic Adaptation System?

    The system was granted FDA 510(k) clearance under the product code HAW, with a decision of Substantially Equivalent (SESE) by the Neurology (NE) advisory committee in 1986. The clearance number is K862220, and it follows a traditional review pathway.