Gromment Style Venturi Tube

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

510(k) Number

K943849 ↗

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 primary purpose of the Gromment Style Venturi Tube and who should use it?

  The Gromment Style Venturi Tube is designed specifically for tympanostomy procedures to maintain ventilation and drainage in the middle ear. It is intended for surgical insertion by otolaryngologists (ear, nose, and throat specialists) to address conditions requiring middle ear aeration, such as chronic ear infections or fluid buildup.

• Is the Gromment Style Venturi Tube meant for single-use or can it be reused?

  The Gromment Style Venturi Tube is supplied as a single-use, sterile product. This ensures patient safety and compliance with sterile medical device protocols, preventing cross-contamination or degradation from repeated use.

• How should the Gromment Style Venturi Tube be stored to maintain its sterility?

  Since the device is sterile upon packaging, it must be stored according to standard sterile medical device protocols. This typically includes keeping it in its original, unopened packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures to preserve sterility and functionality.

• What regulatory pathway does the Gromment Style Venturi Tube follow, and what does that mean for its use?

  The Gromment Style Venturi Tube follows the FDA’s 510(k) clearance pathway, specifically under the product code ETD (Ear, Nose, Throat Devices) and classified as a Class II medical device. This means it has been determined to be substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness, ensuring it can be legally marketed and used in the U.S. for its intended purpose.