Prosthesis, Larynx (Stents And Keels)
A laryngeal prosthesis, including stents and keels, is a device implanted or placed in the larynx to maintain patency, support vocal fold function, or prevent stenosis following laryngeal surgery or injury. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FWN, regulated under 21 CFR 874.3620, within the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FWN
- Device Class
- FDA class 2
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091135 | RUTTER SUPRA STOMAL STENTS | Sep 14, 2009 | Substantially Equivalent | Boston Medical Products, Inc. |
| K000154 | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 | Mar 29, 2000 | Substantially Equivalent | E. Benson Hood Lab, Inc. |
| K962693 | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | Aug 09, 1996 | Substantially Equivalent | Boston Medical Products, Inc. |
| K896667 | LORENZ STENT | Feb 22, 1990 | Substantially Equivalent | Walter Lorenz Surgical, Inc. |
| K884810 | SILICONE LARYNGEAL STENT | May 10, 1989 | Substantially Equivalent | Hood Laboratories |
| K864936 | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL | Apr 27, 1987 | Substantially Equivalent | Exmoor Plastics , Ltd. |
| K853726 | LARYNGEAL | Mar 12, 1986 | Substantially Equivalent | Hood Laboratories |
| K842800 | MONTG. LARYNGEAL KEEL | Aug 02, 1984 | Substantially Equivalent | Boston Medical Products, Inc. |
| K842287 | MONTGOMERY LARYNGEAL STENT | Jun 27, 1984 | Substantially Equivalent | Boston Medical Products, Inc. |
| K841347 | LARYNGEAL STENT | May 02, 1984 | Substantially Equivalent | E. Benson Hood Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.