Eliachar Laryngeal Foam Stent, Model ELL-1

FDA 510(k) K000154 · E. Benson Hood Lab, Inc.

Substantially Equivalent

510(k) numberK000154

Submission

Device name
Eliachar Laryngeal Foam Stent, Model ELL-1
Applicant
E. Benson Hood Lab, Inc.
Pembroke, MA, US
Received
January 19, 2000
Decision date
March 29, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FWN – Prosthesis, Larynx (Stents And Keels)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3620
Specialty
Ear, Nose, Throat

Other 510(k)s with product code FWN

510(k)DeviceApplicantDecision
K091135Rutter Supra Stomal StentsFWN · Traditional Boston Medical Products, Inc.09/14/2009SE
K962693Montgomery Radiopaque Laryngeal KeelFWN · Traditional Boston Medical Products, Inc.08/09/1996SE
K896667Lorenz StentFWN · Traditional Walter Lorenz Surgical, Inc.02/22/1990SE
K884810Silicone Laryngeal StentFWN · Traditional Hood Laboratories05/10/1989SE
K864936'Exmoor' Das Gupta Laryngeal KeelFWN · Traditional Exmoor Plastics , Ltd.04/27/1987SE
K853726LaryngealFWN · Traditional Hood Laboratories03/12/1986SE
K842800Montg. Laryngeal KeelFWN · Traditional Boston Medical Products, Inc.08/02/1984SE
K842287Montgomery Laryngeal StentFWN · Traditional Boston Medical Products, Inc.06/27/1984SE
K841347Laryngeal StentFWN · Traditional E. Benson Hood Laboratories, Inc.05/02/1984SE

More from E. Benson Hood Laboratories, Inc.

510(k)DeviceDecision
K011329Eccovision Acoustic Diagnostic Imaging Acoustic PharyngometerBXQ · Traditional 07/26/2002SE
K974132Voice Master ProsthesisEWL · Traditional 02/25/1998SE

Questions and answers

When was Eliachar Laryngeal Foam Stent, Model ELL-1 cleared by the FDA?

Eliachar Laryngeal Foam Stent, Model ELL-1 (K000154) received a 510(k) decision of Substantially Equivalent on March 29, 2000, 70 days after the submission was received.

What is the product code of K000154?

The FDA product code is FWN – Prosthesis, Larynx (Stents And Keels), a Class II (moderate risk) device regulated under 21 CFR 874.3620.