FWN · Class II · 21 CFR 874.3620

FDA Product Code FWN: Prosthesis, Larynx (stents And Keels)

Leading manufacturers include Boston Medical Products, Inc., Hood Laboratories and E. Benson Hood Lab, Inc..

10
Total
10
Cleared
88d
Avg days
1984
Since

FDA 510(k) Cleared Prosthesis, Larynx (stents And Keels) Devices (Product Code FWN)

10 devices
1–10 of 10
Cleared Sep 14, 2009
RUTTER SUPRA STOMAL STENTS
K091135
Boston Medical Products, Inc.
Ear, Nose, Throat · 147d
Cleared Mar 29, 2000
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
K000154
E. Benson Hood Lab, Inc.
Ear, Nose, Throat · 70d
Cleared Aug 09, 1996
MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
K962693
Boston Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Feb 22, 1990
LORENZ STENT
K896667
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 87d
Cleared May 10, 1989
SILICONE LARYNGEAL STENT
K884810
Hood Laboratories
Ear, Nose, Throat · 174d
Cleared Apr 27, 1987
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
K864936
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 132d
Cleared Mar 12, 1986
LARYNGEAL
K853726
Hood Laboratories
Ear, Nose, Throat · 187d
Cleared Aug 02, 1984
MONTG. LARYNGEAL KEEL
K842800
Boston Medical Products, Inc.
Ear, Nose, Throat · 16d
Cleared Jun 27, 1984
MONTGOMERY LARYNGEAL STENT
K842287
Boston Medical Products, Inc.
Ear, Nose, Throat · 12d

About Product Code FWN - Regulatory Context