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Diego Elite BB4000SS

by Gyrus Acmi, Inc.

Diego Elite BB4000SS is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K123429 on 5 Apr 2013 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 00821925038134), active as of 23 Oct 2026. 12 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 closed

Documents

510(k) K123429

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00821925038134 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123429 Date5 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123429 decided 5 Apr 2013 Active
  • FDA GUDID UDI-DI 00821925038134 listed 13 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

14 dated events

  1. Recall initiated FDA recalls Z-1181-2019
  2. Recall initiated FDA recalls Z-1184-2019
  3. Recall initiated FDA recalls Z-1178-2019
  4. Recall initiated FDA recalls Z-1186-2019
  5. Recall initiated FDA recalls Z-1185-2019
  6. Recall initiated FDA recalls Z-1182-2019
  7. Recall initiated FDA recalls Z-1179-2019
  8. Recall initiated FDA recalls Z-1183-2019
  9. Recall initiated FDA recalls Z-1187-2019
  10. Recall initiated FDA recalls Z-1180-2019

4 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diego Elite
Generic name
ENT shaver system
Model / reference
BB4000SS
Primary DI / UDI-DI
00821925038134
510(k) Number
FDA product code
GEI
GMDN term
ENT shaver system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

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.

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 (10, all answered No)