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Electrosurgical generator ESG-410

by Olympus Winter & Ibe GmbH 3 variants

Ref WA91327W

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4042761110845C Basic UDI-DI 04042761087704UDI-DIDate5 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761087704 UDI-DI Date22 Dec 2023ListedStatusListed GUDID: in commercial distribution

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

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2338-2025 FDA Class II initiated 25 Jul 2025

    Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.

    • Ongoing Z-0264-2025 FDA Class II initiated 4 Sep 2024

    There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Electrosurgical generator ESG-410 EUDAMED
Olympus GUDID
Generic Name
Electrosurgical/ultrasonic surgical system generator
Device Name
Electrosurgical Generators - ESG-410 ARTUS
Model / Ref / Catalog
WA91327W
Primary DI / UDI-DI
04042761087704
Basic UDI-DI
4042761110845C
Direct Marketing DI
04042761087704
510(k) Number
FDA Product Code
GEI
EMDN Code
Z12010880, Z12010905
GMDN Term
Electrosurgical/ultrasonic surgical system generator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006729

Other devices from Olympus Winter & Ibe GmbH

See all devices from Olympus Winter & Ibe GmbH →

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