Grommet Vent Tube

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K823908 ↗

FDA Product Code

ETD

Device Class

Class II

Regulation

21 CFR Part 874.3880

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Mcgee 26GA. Suction Tube

  Class I

  FDA 510(k) K823437 Active Cleared 9 Dec 1982

• Armstrong V Tube Suction Inserter

  Class I

  FDA 510(k) K822349 Active Cleared 13 Sep 1982

• Vein Graft Ear Scissors

  Class I

  FDA 510(k) K870756 Active Cleared 3 Mar 1987

• Microsurgical Gauge

  Class I

  FDA 510(k) K823436 Active Cleared 9 Dec 1982

• Universal Speculum Holder

  Class I

  FDA 510(k) K822370 Active Cleared 9 Sep 1982

• Tytan Reuter Bobbin Vent Tube

  Class II

  FDA 510(k) K822376 Active Cleared 9 Sep 1982

See all devices from Treace Medical, Inc. →

• What is the Grommet Vent Tube designed for?

  The Grommet Vent Tube is specifically designed for middle ear ventilation in otolaryngological procedures. It facilitates drainage of fluid and equalizes pressure within the middle ear, which is particularly useful in managing conditions like otitis media with effusion or recurrent ear infections. The grommet ensures secure placement within the tympanic membrane while allowing continuous airflow.

• How is the Grommet Vent Tube supplied and intended for use?

  The Grommet Vent Tube is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for optimal performance during the procedure. It is meant for use by trained healthcare professionals in clinical settings, adhering to sterile technique protocols.

• Is the Grommet Vent Tube reusable or single-use?

  The Grommet Vent Tube is explicitly designed for single-use only. This is a standard practice for medical devices intended for insertion into the body to minimize infection risks and ensure reliability. Reuse is not recommended or supported by the manufacturer.

• What sizes are available for the Grommet Vent Tube?

  The Grommet Vent Tube is available in a specified size of .040, which is tailored for appropriate placement within the tympanic membrane. The sizing ensures compatibility with common clinical needs for tympanostomy procedures. Additional sizes may vary, but the .040 is prominently listed in the specifications.

• How should the Grommet Vent Tube be stored?

  Since the Grommet Vent Tube is supplied sterile, it should be stored in its original packaging until ready for use. The packaging is designed to maintain sterility, so it should remain unopened and protected from contamination until the procedure. Always follow the manufacturer’s storage guidelines to preserve the device’s integrity.