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Pro-000-310

by Summit Medical, LLC

Ref PRO-000-310

Pro-000-310 is a tympanostomy tube (EU MDD Class IIb; FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Summit Medical, LLC, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00385640027113), cleared under FDA 510(k) K830228 on 7 Mar 1983 and listed in FDA GUDID since 14 Feb 2017 (UDI-DI 00385640027113), active as of 7 Nov 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) K830228

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-00385640027113 Basic UDI-DI 00385640027113UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00385640027113 UDI-DI Date14 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK830228 Date7 Mar 1983DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00385640027113 registered 6 Nov 2026 Active
  • FDA 510(k) K830228 decided 7 Mar 1983 Active
  • FDA GUDID UDI-DI 00385640027113 listed 14 Feb 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-1731-2014 FDA Class II initiated 12 May 2014

    One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.

Timeline

4 dated events

  1. Cleared FDA 510(k) K830228
  2. Recall initiated FDA recalls Z-1731-2014
  3. Listed FDA GUDID 00385640027113
  4. Registered EUDAMED B-00385640027113

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  • Withdrawn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
SHEPARD WITH WIRE, 1.0mm Lumen, Fluoroplastic
Generic name
Tympanostomy tube
Device name
Otological Ventilation Tubes
Model / reference
PRO-000-310
Primary DI / UDI-DI
00385640027113
Basic UDI-DI
B-00385640027113
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
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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 (K830228)

and 8 more cleared under K830228

Similar devices in this category

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

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)