Skip to content

Diego Elite BB4000SC

by Gyrus Acmi, Inc.

Ref BB4000SC

Diego Elite BB4000SC 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 9 Sep 2026 (Basic UDI-DI B-00821925043077), cleared under FDA 510(k) K123429 on 5 Apr 2013 and listed in FDA GUDID since 25 Jul 2024 (UDI-DI 00821925043077), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925043077 Basic UDI-DI 00821925043077UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925043077 UDI-DI Date25 Jul 2024ListedStatusListed 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-00821925043077 registered 9 Sep 2026 Active
  • FDA 510(k) K123429 decided 5 Apr 2013 Active
  • FDA GUDID UDI-DI 00821925043077 listed 25 Jul 2024 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-1178-2019
  2. Recall initiated FDA recalls Z-1186-2019
  3. Recall initiated FDA recalls Z-1185-2019
  4. Recall initiated FDA recalls Z-1182-2019
  5. Recall initiated FDA recalls Z-1179-2019
  6. Recall initiated FDA recalls Z-1183-2019
  7. Recall initiated FDA recalls Z-1187-2019
  8. Recall initiated FDA recalls Z-1180-2019
  9. Listed FDA GUDID 00821925043077
  10. Registered EUDAMED B-00821925043077

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
ENT shaver system
Device name
BB4000SC
Model / reference
BB4000SC
Primary DI / UDI-DI
00821925043077 EUDAMED
00821925043084 GUDID
Basic UDI-DI
B-00821925043077
510(k) Number
FDA product code
GEI
EMDN code
Q030302 ENT surgery burs and handpieces, single-use
GMDN term
ENT shaver 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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925043077
GUDID
00821925043084
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925043077; FDA GUDID lists 00821925043084), so their flags are not compared. 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: ENT shaver system

Cleared under the same submission (K123429)

and 8 more cleared under K123429

Similar devices

Also classified as ENT shaver system.

Similar devices in this category

Other devices filed under ENT SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)