Pappas Tri-Flange Ventilation Tube

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K895242 ↗

FDA Product Code

ETD

Device Class

Class II

Regulation

21 CFR Part 874.3880

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from Richards Medical Co., Inc. →

• What is the purpose of the Pappas Tri-Flange Ventilation Tube?

  The Pappas Tri-Flange Ventilation Tube is a tympanostomy tube designed to provide ventilation to the middle ear by creating a passage through the tympanic membrane. It helps maintain proper ear pressure and drainage.

• Is the Pappas Tri-Flange Ventilation Tube single-use or reusable?

  The Pappas Tri-Flange Ventilation Tube is supplied as either a single-use or reusable product depending on the specific model selected. Users should follow the manufacturer's instructions for the particular model they are using.

• What sizes and models are available for the Pappas Tri-Flange Ventilation Tube?

  The Pappas Tri-Flange Ventilation Tube is available in various sizes to accommodate different patient needs. The specific sizes and models should be selected based on clinical requirements and patient anatomy.

• What is the regulatory status of the Pappas Tri-Flange Ventilation Tube?

  The Pappas Tri-Flange Ventilation Tube is regulated under FDA 510(k) clearance K895242 as a class II medical device for the Ear, Nose, and Throat specialty, with product code ETD.