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Micron 145280-Ent

by Gyrus Acmi, Inc.

Ref 145280-ENT

Micron 145280-Ent is a tympanostomy tube (EU MDD Class IIb; FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Gyrus Acmi, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-00821925018204), cleared under FDA 510(k) K820362 on 2 Mar 1982 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00821925018204), active as of 25 Oct 2026. One FDA recall is 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K820362

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-00821925018204 Basic UDI-DI 00821925018204UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925018204 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK820362 Date2 Mar 1982DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925018204 registered 9 Sep 2026 Active
  • FDA 510(k) K820362 decided 2 Mar 1982 Active
  • FDA GUDID UDI-DI 00821925018204 listed 11 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0797-2010 FDA Unclassified (pre-2012) initiated 8 Jan 2010

    Units of the product in lot MH136952 may have been shipped without being sterilized.

Timeline

4 dated events

  1. Cleared FDA 510(k) K820362
  2. Recall initiated FDA recalls Z-0797-2010
  3. Listed FDA GUDID 00821925018204
  4. Registered EUDAMED B-00821925018204

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  • Withdrawn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
Micron
Generic name
Tympanostomy tube
Device name
145280-Ent
Model / reference
145280-ENT
Primary DI / UDI-DI
00821925018204 EUDAMED
00821925032422 GUDID
Basic UDI-DI
B-00821925018204
510(k) Number
FDA product code
ETD
EMDN code
Q03040199 Ear drainage and ventilation devices - other
GMDN term
Tympanostomy tube
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
874.3880
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925018204
GUDID
00821925032422
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925018204; FDA GUDID lists 00821925032422), so their flags are not compared. 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: Tympanostomy tube

Cleared under the same submission (K820362)

and 8 more cleared under K820362

Similar devices in this category

Other devices filed under EAR DRAINAGE AND VENTILATION DEVICES - OTHER.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)