Tympanostomy Tubes

510(k) Number

K232059 ↗

FDA product code

ETD

Device class

Class II

Regulation

21 CFR Part 874.3880

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code ETD (Tube, Tympanostomy).

• GYRUS ACMI 70143265 by Gyrus Acmi, Inc.
• GYRUS ACMI 70241000 by Gyrus Acmi, Inc.
• T-TUBE VENT TUBE by Treace Medical, Inc.
• TYMPOVENT by Atos Medical AB
• BOBBIN STYLE VENTURI VENT TUBE by Micromed Development Corp.
• C-FLEX VENT TUBES by Micromed Development Corp.
• JAHN VENTILATION TUBE by Smith & Nephew Richards, Inc.
• TYMPANOSTOMY (VENTILATION) TUBE by Xomed-Treace, Inc.
• Neozoline Ventilation Tubes by Adept Medical Ltd
• Ventilation (Tympanostomy) Tubes by Medtronic Xomed Inc

• Titanium/Fluoroplastic Piston 409-600 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-525 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-550 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

• Grace Piston 412-575 Open recall

  Class II

  FDA 510(k) K060518 Active Cleared 28 Jun 2006 GUDID on market

See all devices from Grace Medical, Inc. →