Manufacturer
Erbe Elektromedizin GmbHErbe ESU Model VIO® 3n with Accessories
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251108
- Device name
- Erbe ESU Model VIO® 3n with Accessories
- Company
- Erbe Elektromedizin GmbH
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-04-11
- Decision date
- 2025-08-29
- Submission type
- Traditional
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Intended Use
The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Device Description
The Erbe ESU Model VIO® 3n is an electrosurgical unit (ESU) that delivers high-frequency (HF) electrical current for cutting and/or coagulation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different footswitches are available for activating the ESU. The ESU VIO® 3n has several clearly defined monopolar and bipolar cutting and coagulation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. In combination with the compatible argon plasma coagulation unit APC 3 (K191234), it offers monopolar modes for argon plasma coagulation and argon-supported modes. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle. Connections for the central power supply, for footswitches, for potential equalization of the operating theatre and Erbe Communication Bus (ECB) connections to other Erbe modules are located at the rear. The ESU emits sounds when instruments are activated, and messages are signaled. The actual application is carried out using compatible electrosurgical instruments that are connected to the generator. The VIO® 3n can be combined with matching Erbe devices and modules, instruments, and accessories. To address various clinical needs, the ESU is available in 5 different configurations which are called 'Fire', 'Metal', 'Stone', 'Water' and 'Timber'. Whereas the configuration 'Fire' includes all available modes and functionalities, the other configurations only offer a reduced number of modes and functionalities.
Summary parsed at:2026-06-20 17:48:43 UTC
