Tympanostomy Ventilation Tube

FDA 510(k) K971454 · Ikonos Corp.

Substantially Equivalent

510(k) numberK971454

Submission

Device name
Tympanostomy Ventilation Tube
Applicant
Ikonos Corp.
Portland, OR, US
Received
April 21, 1997
Decision date
May 29, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ETD – Tube, Tympanostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3880
Specialty
Ear, Nose, Throat
Implant
Yes

Other 510(k)s with product code ETD

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K252436Tula Tympanostomy Tube Delivery DeviceETD · Traditional Tusker Medical, Inc.04/23/2026SE
K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…ETD · Traditional Aventamed Dac04/28/2025SE
K232702Solo+ Tympanostomy Tube Device (TTD)ETD · Traditional Aventamed Dac05/20/2024SE
K233658Biowy Tym Tube (TT)ETD · Traditional Biowy Corporation02/16/2024SE
K232059Tympanostomy TubesETD · Traditional Grace Medical, Inc.11/24/2023SE
K221254Hummingbird Tympanostomy Tube SystemETD · Traditional Preceptis Medical, Inc.07/27/2022SE
K200952Hummingbird Tympanostomy Tube SystemETD · Traditional Preceptis Medical, Inc.06/05/2020SE
K171239TULA Tube Delivery SystemETD · Special Tusker Medical06/28/2017SE
K151830Hummingbird Tympanostomy TubeETD · Traditional Preceptis Medical09/21/2015SE
K151067Ventilation (Tympanostomy) TubesETD · Traditional Medtronic Xomed, Inc.07/22/2015SE

More from Medtronic Xomed, Inc.

510(k)DeviceDecision
K971252Sevrain Cranial ClampGXN · Traditional 07/06/1998SE
K971408Sevrain Cranial Clamp (SCC-200 Series)GXN · Traditional 05/12/1998SE

Questions and answers

When was Tympanostomy Ventilation Tube cleared by the FDA?

Tympanostomy Ventilation Tube (K971454) received a 510(k) decision of Substantially Equivalent on May 29, 1997, 38 days after the submission was received.

What is the product code of K971454?

The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.