Erbe Vio Esu, Model Vio 300 D
by Erbe USA, Inc. 510(k)
Active
510(k) K060484
Overview
The ERBE VIO ESU, Model VIO 300 D, is an electrosurgical unit (ESU) designed to deliver high-frequency electrical current for tissue cutting and coagulation. Classified under the product code GEI (Electrosurgical Cutting and Coagulation Devices), it operates by converting electrical energy into thermal energy to achieve precise surgical effects. This device is intended for use in general and plastic surgery procedures where controlled tissue modification is required. Its functionality aligns with the definition of an electrosurgical generator, enabling both monopolar and bipolar modes for versatile surgical applications.
The ERBE VIO 300 D is supplied as a reusable medical device and is intended for use in clinical settings such as operating rooms and surgical suites. It is not sterile at the time of shipment but is designed to be cleaned and reprocessed according to established protocols. The device has been granted FDA 510(k) clearance under Special Review (K060484) and is intended for use in the United States. No specific MRI safety information is provided in the available data, and its dimensions or storage requirements are not detailed in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060484 | Date16 Mar 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
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
Other devices from Erbe USA, Inc.
Questions
What is the ERBE VIO 300 D electrosurgical unit used for?
The ERBE VIO 300 D is designed to provide controlled tissue modification through high-frequency electrical current, enabling precise cutting and coagulation during surgical procedures. It is particularly suited for general and plastic surgery applications where accurate and versatile surgical effects are required.
Is the ERBE VIO 300 D a reusable or single-use device?
The ERBE VIO 300 D is a reusable medical device. It is intended for use in clinical settings such as operating rooms and surgical suites, where it must be cleaned and reprocessed according to established protocols before each use.
How is the sterility of the ERBE VIO 300 D ensured?
The device is not sterile at the time of shipment. Sterility is achieved through proper cleaning and reprocessing following manufacturer guidelines and clinical protocols before each use to maintain a sterile field during surgery.
What modes of operation does the ERBE VIO 300 D support?
The ERBE VIO 300 D supports both monopolar and bipolar modes, providing versatility for different surgical techniques and tissue types. This dual-mode capability allows clinicians to select the most appropriate setting for their specific procedure.
What regulatory clearance does the ERBE VIO 300 D hold?
The ERBE VIO 300 D has received FDA 510(k) clearance under Special Review (K060484), confirming it is substantially equivalent to a predicate device and approved for use in the United States. This clearance is specific to its classification as an electrosurgical cutting and coagulation device.