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Diego Elite NCGRIP

by Gyrus Acmi, Inc.

Ref NCGRIP

Diego Elite NCGRIP 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-00821925040694), cleared under FDA 510(k) K123429 on 5 Apr 2013 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 00821925040694), 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-00821925040694 Basic UDI-DI 00821925040694UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925040694 UDI-DI Date5 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-00821925040694 registered 2 Nov 2026 Active
  • FDA 510(k) K123429 decided 5 Apr 2013 Active
  • FDA GUDID UDI-DI 00821925040694 listed 5 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-00821925040694

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
Ncgrip
Model / reference
NCGRIP
Primary DI / UDI-DI
00821925040694 EUDAMED
00821925040700 GUDID
Basic UDI-DI
B-00821925040694
510(k) Number
FDA product code
GEI
EMDN code
Z12149080 Various ENT instruments - hardware accessories
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
00821925040694
GUDID
00821925040700
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925040694; FDA GUDID lists 00821925040700), 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 VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES.

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)