FWN
10 FDA 510(k) clearances · Product code
87 daysmedian time to decision
187 days90th percentile
10clearances measured
FDA profile
- Official device name
- Prosthesis, Larynx (Stents And Keels)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1997: 1 · 1999: 1 · 2000: 2 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RUTTER SUPRA STOMAL STENTS (K091135) | Boston Medical Products, Inc. | 2009-09-14 |
| ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (K000154) | E. Benson Hood Lab, Inc. | 2000-03-29 |
| MONTGOMERY RADIOPAQUE LARYNGEAL KEEL (K962693) | Boston Medical Products, Inc. | 1996-08-09 |
| LORENZ STENT (K896667) | Walter Lorenz Surgical, Inc. | 1990-02-22 |
| SILICONE LARYNGEAL STENT (K884810) | Hood Laboratories | 1989-05-10 |
| 'EXMOOR' DAS GUPTA LARYNGEAL KEEL (K864936) | Exmoor Plastics , Ltd. | 1987-04-27 |
| LARYNGEAL (K853726) | Hood Laboratories | 1986-03-12 |
| MONTG. LARYNGEAL KEEL (K842800) | Boston Medical Products, Inc. | 1984-08-02 |
| MONTGOMERY LARYNGEAL STENT (K842287) | Boston Medical Products, Inc. | 1984-06-27 |
| LARYNGEAL STENT (K841347) | E. Benson Hood Laboratories, Inc. | 1984-05-02 |
Track FWN automatically
Every clearance here is in the API, with alerts when new ones post.