FWN · Prosthesis, Larynx (Stents And Keels)
Ear, Nose, Throat · 21 CFR 874.3620 · Class 2
Overview
| Product Code | FWN |
|---|---|
| Device Name | Prosthesis, Larynx (Stents And Keels) |
| Regulation | 21 CFR 874.3620 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
Classification Rationale
Class II.
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091135 | RUTTER SUPRA STOMAL STENTS | Boston Medical Products, Inc. | Sep 14, 2009 | SESE |
| K000154 | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 | E. Benson Hood Lab, Inc. | Mar 29, 2000 | SESE |
| K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | Boston Medical Products, Inc. | Aug 9, 1996 | SESE |
| K896667 | LORENZ STENT | Walter Lorenz Surgical, Inc. | Feb 22, 1990 | SESE |
| K884810 | SILICONE LARYNGEAL STENT | Hood Laboratories | May 10, 1989 | SESE |
| K864936 | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL | Exmoor Plastics , Ltd. | Apr 27, 1987 | SESE |
| K853726 | LARYNGEAL | Hood Laboratories | Mar 12, 1986 | SESE |
| K842800 | MONTG. LARYNGEAL KEEL | Boston Medical Products, Inc. | Aug 2, 1984 | SESE |
| K842287 | MONTGOMERY LARYNGEAL STENT | Boston Medical Products, Inc. | Jun 27, 1984 | SESE |
| K841347 | LARYNGEAL STENT | E. Benson Hood Laboratories, Inc. | May 2, 1984 | SESE |
Top Applicants
- Boston Medical Products, Inc. — 4 clearances
- Hood Laboratories — 2 clearances
- Walter Lorenz Surgical, Inc. — 1 clearance
- Exmoor Plastics , Ltd. — 1 clearance
- E. Benson Hood Laboratories, Inc. — 1 clearance
