FWN — Prosthesis, Larynx (Stents And Keels) Class II
FDA product code FWN covers "Prosthesis, Larynx (Stents And Keels)", a Class II medical device regulated under 21 CFR 874.3620. Submissions are reviewed by the Ear, Nose, Throat panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FWN
- Device Class
- Class II
- Regulation Number
- 874.3620
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K091135 | boston medical products | RUTTER SUPRA STOMAL STENTS | September 14, 2009 |
| K000154 | e. benson hood lab | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 | March 29, 2000 |
| K962693 | boston medical products | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | August 9, 1996 |
| K896667 | walter lorenz surgical | LORENZ STENT | February 22, 1990 |
| K884810 | hood laboratories | SILICONE LARYNGEAL STENT | May 10, 1989 |
| K864936 | exmoor plastics | 'EXMOOR' DAS GUPTA LARYNGEAL KEEL | April 27, 1987 |
| K853726 | hood laboratories | LARYNGEAL | March 12, 1986 |
| K842800 | boston medical products | MONTG. LARYNGEAL KEEL | August 2, 1984 |
| K842287 | boston medical products | MONTGOMERY LARYNGEAL STENT | June 27, 1984 |
| K841347 | e. benson hood laboratories | LARYNGEAL STENT | May 2, 1984 |