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Diego Elite MDCONS100

by Gyrus Acmi, Inc.

Ref MDCONS100

Diego Elite MDCONS100 is a device classified as Class IIa in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00821925027770), cleared under FDA 510(k) K123429 on 5 Apr 2013 and listed in FDA GUDID since 14 Oct 2016 (UDI-DI 00821925027770), active as of 7 Nov 2026. 12 FDA recalls are linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

12 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123429

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925027770 Basic UDI-DI 00821925027770UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925027770 UDI-DI Date14 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123429 Date5 Apr 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925027770 registered 2 Nov 2026 Active
  • FDA 510(k) K123429 decided 5 Apr 2013 Active
  • FDA GUDID UDI-DI 00821925027770 listed 14 Oct 2016 Listed

Recalls

12 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-1181-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1184-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1178-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1186-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1185-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1182-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1179-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1183-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1187-2019 FDA Class II initiated 8 Mar 2019
    • Terminated Z-1180-2019 FDA Class II initiated 8 Mar 2019

    Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

  • 2 recalls, same reason

    • Terminated Z-1752-2015 FDA Class II initiated 8 May 2015
    • Terminated Z-1753-2015 FDA Class II initiated 8 May 2015

    Potential lack of sterility assurance.

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-1184-2019
  2. Recall initiated FDA recalls Z-1178-2019
  3. Recall initiated FDA recalls Z-1186-2019
  4. Recall initiated FDA recalls Z-1185-2019
  5. Recall initiated FDA recalls Z-1182-2019
  6. Recall initiated FDA recalls Z-1179-2019
  7. Recall initiated FDA recalls Z-1183-2019
  8. Recall initiated FDA recalls Z-1187-2019
  9. Recall initiated FDA recalls Z-1180-2019
  10. Registered EUDAMED B-00821925027770

5 earlier events are in the sections above.

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Diego Elite
Generic name
Electrosurgical system
Device name
MDCONS100
Model / reference
MDCONS100
Primary DI / UDI-DI
00821925027770
Basic UDI-DI
B-00821925027770
510(k) Number
FDA product code
GEI
EMDN code
Z120615 Therapeutic lasers
GMDN term
Electrosurgical system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00821925027770: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa 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 system

Cleared under the same submission (K123429)

and 8 more cleared under K123429

Similar devices in this category

Other devices filed under THERAPEUTIC LASERS.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)