Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
by Conmed Corporation EUDAMED510(k)
Active
510(k) K214058
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK214058 | Date26 Aug 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Beamer AVEO system is an electrosurgical generator designed for precise tissue cutting, coagulation, and desiccation in surgical procedures. It integrates a generator, argon module, cart, foot pedal, and pressure reducer to deliver controlled electrosurgical energy and argon plasma coagulation for general and plastic surgery applications.
The system is supplied as a reusable, modular setup intended for use in operating rooms and surgical suites. Components include a main generator, an argon plasma module, a cart for housing accessories, a wired foot pedal for operator control, and an argon pressure reducer. The device is regulated under FDA 510(k) clearance (K214058) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). No specific sterility or MRI safety information is provided in the data.
Other devices from Conmed Corporation
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures is the Beamer AVEO system intended for, and how does it differ from other electrosurgical generators?
The Beamer AVEO system is designed for general and plastic surgery, delivering precise electrosurgical energy for cutting, coagulation, and desiccation. It integrates a generator, argon plasma module, and accessories to provide controlled energy delivery, including argon plasma coagulation—a feature that distinguishes it from standard generators lacking this capability. The modular setup (cart, foot pedal, pressure reducer) ensures flexibility for various surgical needs in operating rooms.
Is the Beamer AVEO system reusable, and if so, how should its components be maintained?
Yes, the Beamer AVEO system is reusable and modular, meaning its core components (generator, argon module, cart, foot pedal, and pressure reducer) are intended for repeated use in surgical settings. While the data does not specify cleaning or sterilization protocols, reusable medical devices typically require adherence to manufacturer guidelines for disinfection and maintenance to ensure safety and functionality. Always follow Conmed Corporation’s instructions for proper upkeep.
What regulatory pathways has the Beamer AVEO system undergone, and what does this mean for its use in clinical settings?
The Beamer AVEO system has undergone FDA 510(k) clearance (K214058) under the Traditional pathway, demonstrating it is *substantially equivalent* to a legally marketed predicate device. It also complies with the EU Medical Device Directive (MDD) and Medical Device Regulation (MDR), ensuring it meets stringent safety and performance standards for use in operating rooms. This regulatory route confirms its suitability for general and plastic surgery applications as intended by the manufacturer.
Are there different models or sizes available for the Beamer AVEO system, and how would a clinician choose the right configuration?
The Beamer AVEO system is described as a modular setup, consisting of a generator, argon module, cart, foot pedal, and pressure reducer—all designed to work together as a cohesive unit. While the data does not specify multiple