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Cbyon Surgical Operating System (SOS)

by Cbyon, Inc.

510(k) K000171

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 NumberK000171 Date13 Mar 2000ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The Cbyon Surgical Operating System (SOS) is a Neurological Stereotaxic Instrument designed for surgical navigation. It provides precise spatial orientation and guidance during procedures, supporting applications in spinal, cranial, and ENT surgeries by integrating imaging and real-time tracking technologies.

The system is intended for use in operating room environments and has received FDA 510(k) clearance under the product code HAW. It is classified as a Class II device under regulation 882.4560, with a decision of Substantially Equivalent (SESE) issued in 2000. No third-party review was conducted, and the device is not specified as single-use or reusable in the available data.

Other devices from Cbyon, Inc.

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of surgical procedures is the Cbyon Surgical Operating System (SOS) designed to assist with in the operating room?

    The Cbyon Surgical Operating System (SOS) is specifically designed to support surgical navigation for spinal, cranial, and ENT (ear, nose, and throat) procedures. It uses imaging and real-time tracking technologies to provide precise spatial orientation and guidance during these surgeries, helping surgeons maintain accuracy and control in complex environments.

  • Is the Cbyon Surgical Operating System (SOS) intended for single-use or reusable applications in the operating room?

    The available data does not specify whether the Cbyon Surgical Operating System (SOS) is intended for single-use or reusable applications. Clinicians or buyers should refer to the manufacturer’s instructions for use or contact Cbyon, Inc. for clarification on proper handling and reprocessing guidelines.

  • How was the FDA clearance for the Cbyon Surgical Operating System (SOS) determined, and what does this mean for its regulatory status?

    The Cbyon Surgical Operating System (SOS) received FDA clearance under a 510(k) submission with a decision labeled Substantially Equivalent (SESE) in 2000. This means the FDA determined it is as safe and effective as a legally marketed predicate device, classifying it as a Class II device under regulation 882.4560. No third-party review was involved in this determination.

  • What is the primary purpose of the advisory committee involvement in the FDA clearance process for this device?

    The Neurology (NE) advisory committee was consulted during the FDA’s review of the Cbyon Surgical Operating System (SOS), as indicated by the advisory_committee_description field. While the committee provided input, the final clearance decision was made without a third-party review, meaning the FDA relied on Cbyon, Inc.’s submission alone for the Substantially Equivalent (SESE) determination.