Shiley Cricothyrotomy Tube

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781639 ↗

FDA Product Code

EQN

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Stockert-Shiley Caps Venous Occlusion Clamp

  Class I

  FDA 510(k) K864890 Active Cleared 19 Feb 1987

• Basic Heater-Cooler Unit, 115/100V 16-02-20

  Class II

  FDA 510(k) K883330 Active Cleared 26 Sep 1988

• Schneider-Shiley Y-Connector with Rotator

  Class II

  FDA 510(k) K862464 Active Cleared 28 Aug 1986

• Expanded Use for Shiley 3l Cardiotomy Reservoir

  Class II

  FDA 510(k) K872721 Active Cleared 23 Sep 1987

• Shiley Venous Reservoir

  Class II

  FDA 510(k) K854841 Active Cleared 10 Feb 1986

• Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K840198 Active Cleared 3 Aug 1984

See all devices from Shiley, Inc. →

• What is the Shiley Cricothyrotomy Tube used for?

  The Shiley Cricothyrotomy Tube is used in Ear, Nose, Throat procedures, specifically for cricothyrotomy, which is an emergency procedure to establish an airway.

• Is the Shiley Cricothyrotomy Tube sterile?

  The device description does not explicitly state sterility, but as a medical device, it is likely supplied sterile to prevent infection and ensure patient safety.

• What is the regulatory classification of the Shiley Cricothyrotomy Tube?

  The Shiley Cricothyrotomy Tube is classified as a Class 2 device with the product code EQN and is regulated by the FDA with the regulation number 874.4760.