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Coopersurgical Model 6080 Smoke Evacuator System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910377

by CooperSurgical, Inc.

Identifiers

510(k) Number
K910377 FDA 510(k)
FDA Product Code
GCX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6740 FDA 510(k)
Regulation Number
880.6740 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Coopersurgical Model 6080 Smoke Evacuator System is a wall-vacuum powered medical device classified as an operating-room suction apparatus. It is designed to evacuate surgical smoke and aerosolized particles generated during procedures, improving operating room air quality and reducing exposure to personnel and patients. This system operates within the general hospital setting, adhering to regulatory standards for surgical smoke management. Its primary function is to connect to standard wall vacuum systems to remove airborne contaminants efficiently during surgical interventions.

This system is intended for reusable use in controlled clinical environments and is not sterile at time of shipment. It is compatible with standard wall vacuum systems in operating rooms and requires proper installation and maintenance as per manufacturer guidelines. The device is regulated under FDA 510(k) clearance (K910377) and falls under the classification of Apparatus, Suction, Operating-room, Wall Vacuum Powered. No specific MRI safety information is provided, and it is supplied as a reusable medical device for surgical smoke evacuation.

Frequently asked questions

Is the Coopersurgical Model 6080 Smoke Evacuator System designed for single-use or reusable applications in the operating room?

The Coopersurgical Model 6080 Smoke Evacuator System is explicitly designed for reusable use in controlled clinical environments. It is not supplied sterile at the time of shipment, meaning it requires cleaning, maintenance, and reprocessing between uses as outlined by the manufacturer’s guidelines. This design aligns with its classification as an operating-room suction apparatus intended for repeated deployment in surgical settings.

How does the Coopersurgical Model 6080 connect to existing hospital infrastructure, and what type of power source does it require?

The system is wall-vacuum powered, meaning it connects directly to standard wall vacuum systems already present in operating rooms. No additional power source is required beyond the hospital’s existing suction infrastructure. This setup ensures compatibility with existing OR environments without needing separate electrical outlets or modifications.

What types of surgical procedures is the Coopersurgical Model 6080 Smoke Evacuator System intended to support, and how does it improve air quality?

While the system is intended for general surgical smoke management in the operating room—such as during laser surgeries, electrosurgery, or other procedures generating aerosolized particles—it is not tied to a specific procedure type. It improves air quality by evacuating surgical smoke and airborne contaminants directly from the OR environment, reducing exposure to personnel and patients. This is achieved through its connection to wall suction systems, which efficiently remove particulates during interventions.

Does the Coopersurgical Model 6080 require any special handling or storage conditions, and is it compatible with MRI environments?

The system does not specify any special storage conditions beyond standard hospital protocols for reusable medical devices. However, it is not labeled for MRI compatibility, meaning it should not be used or stored near MRI machines. Proper installation and maintenance per manufacturer guidelines are required to ensure functionality, but no additional environmental controls (e.g., temperature, humidity) are mentioned in the documentation.

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: CooperSurgical Smoke Evacuation System 6080 User Manual, Cooper Model 6080 Surgical Smoke Evacuation System - eBay, COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM 510(k) K910377 - FDA ..., See Clear® Smoke Evacuation System - CooperSurgical, Used COOPER SURGICAL ( 6080 ) Smoke Evacuator System, Model 6080 Smoke ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA 510(k) K910377 24 fields · synced Sep 20, 2026