Collar Button Style Venturi

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

510(k) Number

K904594 ↗

FDA Product Code

ETD

Device Class

Class II

Regulation

21 CFR Part 874.3880

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• PTFE Piston

  Class II

  FDA 510(k) K913285 Active Cleared 18 Dec 1991

• River Pump

  Class II

  FDA 510(k) K932895 Active Cleared 31 Mar 1994

• Smartdose IV Prefilled Infusion Container

  Class II

  FDA 510(k) K944351 Active Cleared 15 Nov 1995

• Smartdose III Infusion Container

  Class II

  FDA 510(k) K944352 Active Cleared 15 Nov 1995

• H/A Partial - Regular & H/a Partial - Offset

  Class II

  FDA 510(k) K913287 Active Cleared 18 Dec 1991

• River Medical Microdrill System

  Class I

  FDA 510(k) K905437 Active Cleared 30 May 1991

See all devices from River Medical, Inc. →

• What is the Collar Button Style Venturi device used for?

  This device is a tympanostomy tube designed to provide ventilation of the middle ear, helping to equalize pressure and drain fluid in patients with otitis media or Eustachian tube dysfunction.

• How is the Collar Button Style Venturi tympanostomy tube supplied and intended for use?

  The device is supplied in commercial distribution and is intended for use in clinical settings by healthcare professionals for the surgical placement in the tympanic membrane to ventilate the middle ear.

• What regulatory pathway was used for the Collar Button Style Venturi tympanostomy tube?

  The device received FDA 510(k) clearance as substantially equivalent (K904594) on January 28, 1991, based on its comparison to a legally marketed predicate device under the traditional review pathway.