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N/A 0205005

by Summit Medical, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385640020541 UDI-DI Date29 Sep 2016ListedStatusListed GUDID: in commercial distribution

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Tympanostomy tube
Model / Reference
0205005
Primary DI / UDI-DI
00385640020541
510(k) Number
FDA Product Code
ETD
GMDN Term
Tympanostomy tube
Device Class
Class II
Regulation Number
874.3880
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Tympanostomy tube

Cleared under the same submission (K830228)

Show all (12)

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No