Hermes O.R. Control Center Modification

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

Full name

Modification to Hermes O.R. Control Center

510(k) Number

K031382 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Hermes O.R. Control Center Modification

  Class II

  FDA 510(k) K031956 Active Cleared 17 Jul 2003

• Aesop System and Accessories

  Class II

  FDA 510(k) K960655 Active Cleared 3 May 1996

• Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).

  Class II

  FDA 510(k) K991444 Active Cleared 25 Jun 1999

• Zeus Microwrist Robotic Surgical System

  Class II

  FDA 510(k) K013551 Active Cleared 28 Mar 2002

• Modification to Hermes Operating Room Control Center

  Class II

  FDA 510(k) K003222 Active Cleared 3 Nov 2000

• Modification to Hermes O.R. Control Center

  Class II

  FDA 510(k) K031720 Active Cleared 11 Jul 2003

See all devices from Computer Motion, Inc. →

• What types of ancillary surgical devices can be controlled via voice commands with this modification to the Hermes O.R. Control Center?

  This modification integrates voice control functionality specifically for ancillary surgical devices, allowing hands-free operation of compatible equipment during procedures. While the exact devices supported aren’t listed, it is designed to enhance workflows in operating rooms by enabling voice-activated management of systems that interface with the Hermes O.R. Control Center. Always verify compatibility with your specific equipment before use.

• Is this an upgrade to existing hardware, or does it require new equipment to function?

  This is a software or hardware update intended for the existing Hermes O.R. Control Center. It does not require new hardware but must be applied to the current system to enable voice control functionality for ancillary devices. Check with Computer Motion for compatibility with your specific model before installation.

• How is this modification supplied, and what steps are needed to implement it?

  The modification is supplied as either a software or hardware update package for the Hermes O.R. Control Center. Implementation involves applying the update to the existing system, following manufacturer instructions. Since it’s a modification, no additional hardware purchase is required, but compatibility with your current setup must be confirmed. Contact Computer Motion for detailed installation guidance.

• Does this modification include any special handling requirements, such as sterility or single-use considerations?

  The modification itself is not described as sterile or single-use, as it is a software/hardware update for the Hermes O.R. Control Center. Since it operates as an interface system, it does not come into direct contact with patients or sterile fields. However, any ancillary devices controlled via voice commands may have their own sterility or reuse requirements, which should be followed separately.

• What is the regulatory pathway for this modification, and how was substantial equivalence determined?

  This modification received FDA clearance through a 510(k) submission (K031382) under the product code GCJ, with a special clearance decision for substantial equivalence. The determination was made by the FDA’s Gastroenterology and Urology (GU) advisory committee, classifying it as substantially equivalent to a predicate device. The clearance does not imply clinical indications but confirms regulatory compliance for the described voice control functionality in operating room settings.