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Hermes O.R. Control Center Modification

by Computer Motion, Inc. 3 variants

510(k) K031956

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 · Special NumberK031956 Date17 Jul 2003ClearedStatusActive

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  • Withdrawn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)

Full name
Modification to Hermes O.R. Control Center
510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Hermes O.R. Control Center is a computer-driven system that provides voice control for ancillary surgical devices, eliminating the need for manual interface manipulation or verbal communication between the surgeon and staff.

The device is supplied as a modification to the existing Hermes O.R. Control Center and has received FDA 510(k) clearance. It is classified as a class 2 device with product code GCJ and is substantially equivalent to existing devices. The device is intended for use in gastroenterology and urology settings, and its storage and use are subject to standard medical device regulations.

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Questions

AI-generated answers, 25 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 is the Hermes O.R. Control Center modification used for?

    The modification is used to provide voice control for ancillary surgical devices, eliminating manual interface manipulation or verbal communication between the surgeon and staff.

  • Is the Hermes O.R. Control Center modification supplied as a standalone device?

    No, it is supplied as a modification to the existing Hermes O.R. Control Center.

  • What settings is the Hermes O.R. Control Center modification intended for?

    The device is intended for use in gastroenterology and urology settings.