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DUALTO Energy System ETHUSC

by Ethicon Endo-Surgery, LLC

Ref ETHUSC

DUALTO Energy System ETHUSC is a device classified as Class IIb in the EU and Class II in the US made by Ethicon Endo-Surgery, LLC, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 0705036a000887E), cleared under FDA 510(k) K243067 on 17 Jan 2025 and listed in FDA GUDID since 18 Jun 2025 (UDI-DI 20705036038372), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243067

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705036a000887E Basic UDI-DI 20705036038372UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20705036038372 UDI-DI Date18 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243067 Date17 Jan 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0705036a000887E registered 13 May 2026 Active
  • FDA 510(k) K243067 decided 17 Jan 2025 Active
  • FDA GUDID UDI-DI 20705036038372 listed 18 Jun 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243067
  2. Listed FDA GUDID 20705036038372
  3. Registered EUDAMED 0705036a000887E

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Dualto EUDAMED
DUALTO Energy System GUDID
Generic name
Electrosurgical/ultrasonic surgical system generator
Model / Ref / Catalog
ETHUSC
Primary DI / UDI-DI
20705036038372
Basic UDI-DI
0705036a000887E
Direct marketing DI
10705036038375
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical/ultrasonic surgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrosurgical/ultrasonic surgical system generator

Cleared under the same submission (K243067)

and 2 more cleared under K243067

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Ethicon Endo-Surgery, LLC

See all devices from Ethicon Endo-Surgery, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)