Myringotomy Tube

FDA 510(k) K971943 · Mednet Locator, Inc.

Substantially Equivalent

510(k) numberK971943

Submission

Device name
Myringotomy Tube
Applicant
Mednet Locator, Inc.
Memphis, TN, US
Received
May 27, 1997
Decision date
July 23, 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

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K974174UltraburERL · Traditional 03/10/1998SE
K972737Causse PistonETB · Traditional 09/05/1997SE
K972735Total Ossicular Replacement Prosthesis (Torp)ETA · Traditional 09/05/1997SE
K972734Partial Ossicular Replacement Prosthesis (Porp)ETB · Traditional 09/05/1997SE
K972126Myringotomy TubeETD · Traditional 07/29/1997SE
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Questions and answers

When was Myringotomy Tube cleared by the FDA?

Myringotomy Tube (K971943) received a 510(k) decision of Substantially Equivalent on July 23, 1997, 57 days after the submission was received.

What is the product code of K971943?

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