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Erbe ESU Model VIO 3 with Accessories

by Erbe Elektromedizin GmbH EUDAMED510(k)GUDID

Active European Union and United States

510(k) K190823Ref 10160-000

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4050147VIO3-PT Basic UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147015685 UDI-DIDate6 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK190823 Date22 May 2019ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Vio® 3 EUDAMED
Erbe GUDID
Generic Name
Electrosurgical system generator
Device Name
VIO 3 electrosurgical unit
Model / Ref / Catalog
10160-000
Primary DI / UDI-DI
04050147015685
Basic UDI-DI
4050147VIO3-PT
Direct Marketing DI
04050147015685
510(k) Number
FDA Product Code
GEI
EMDN Code
Z12010902 Electrosurgical units (esu) for general use
GMDN Term
Electrosurgical system generator
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4400
Market of Registration
Germany
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Erbe ESU Model VIO 3 with Accessories is an Electrosurgical Unit (ESU), designed for tissue coagulation, cutting, and desiccation in surgical procedures. It employs high-frequency radio waves to achieve precise control over electrical energy delivery, supporting general, plastic, and other surgical specialties requiring electrosurgical techniques.

This device is supplied as a reusable medical instrument, intended for use in controlled clinical environments such as operating rooms and surgical suites. It is not sterile upon delivery and must be sterilized prior to use, adhering to standard medical device reprocessing protocols. The Model VIO 3 is authorized under FDA 510(k) clearance (K190823) and complies with MDR regulations, ensuring adherence to stringent safety and performance standards.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the Erbe ESU Model VIO 3 primarily used for?

    The Erbe ESU Model VIO 3 is designed for general, plastic, and other surgical specialties that require electrosurgical techniques. It provides precise control over tissue coagulation, cutting, and desiccation using high-frequency radio waves, making it versatile for a wide range of surgical applications in controlled clinical environments like operating rooms.

  • Is the Erbe ESU Model VIO 3 a single-use or reusable device, and what does that mean for its maintenance?

    The Erbe ESU Model VIO 3 is a reusable medical instrument, meaning it is not intended for one-time use. After each procedure, it must be thoroughly cleaned, inspected, and sterilized according to standard medical device reprocessing protocols to ensure safety and functionality for subsequent uses.

  • How is the Erbe ESU Model VIO 3 supplied, and what steps are required before first use?

    The device is shipped non-sterile and requires sterilization prior to its first use, as well as after each reuse. Clinicians must follow established reprocessing protocols to ensure it meets safety and sterility standards before use in surgical procedures.

  • What regulatory pathways does the Erbe ESU Model VIO 3 follow, and what does that imply for its safety standards?

    The Erbe ESU Model VIO 3 is authorized under FDA 510(k) clearance (K190823) and complies with MDR (Medical Device Regulation) standards. This implies it has undergone rigorous evaluations to demonstrate substantial equivalence to a predicate device and meets stringent safety, performance, and regulatory requirements for use in clinical settings.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No