Collar Button Venturi Vent Tube

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K943848 ↗

FDA Product Code

ETD

Device Class

Class II

Regulation

21 CFR Part 874.3880

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Micromed Total Regular and Partial Offset

  Class II

  FDA 510(k) K945106 Active Cleared 22 Nov 1994

• Poly Piston

  Class II

  FDA 510(k) K945108 Active Cleared 22 Nov 1994

• Polyethylene Vent Tubes

  Class II

  FDA 510(k) K943281 Active Cleared 24 Aug 1994

• Edi-Bur Microdrill Systems

  Class II

  FDA 510(k) K945438 Active Cleared 22 Nov 1994

• C-Flex Vent Tubes

  Class II

  FDA 510(k) K943190 Active Cleared 24 Aug 1994

• Disposable Joint Aspiration/Injection Diagnostic Kit

  Class II

  FDA 510(k) K945831 Active Cleared 20 Jan 1995

See all devices from Micromed Development Corp. →

• What is the Collar Button Venturi Vent Tube used for?

  The Collar Button Venturi Vent Tube is a tympanostomy tube designed for ear, nose, and throat procedures. It functions as a ventilation tube to help maintain middle ear pressure and drainage.

• Is the Collar Button Venturi Vent Tube single-use or reusable?

  The Collar Button Venturi Vent Tube is supplied as a single-use item and is not intended for reuse. This design ensures patient safety and prevents cross-contamination between procedures.

• What sizes and models are available for the Collar Button Venturi Vent Tube?

  The Collar Button Venturi Vent Tube is available in various sizes to accommodate different patient needs. The specific sizes and models are determined by the manufacturer, Micromed Development Corp., based on clinical requirements.

• What is the regulatory status of the Collar Button Venturi Vent Tube?

  The Collar Button Venturi Vent Tube is regulated under FDA 510(k) clearance K943848 and is classified under product code ETD for regulatory purposes. It has been determined to be substantially equivalent to predicate devices.