FDA product code FWN: Prosthesis, Larynx (Stents And Keels)
FWN is the FDA product code for prosthesis, larynx (stents and keels). It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 10 510(k) submissions under FWN, from 6 different applicants. The average 510(k) review took 88 days (median 78). FDA has posted 1 recall for FWN devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Larynx (Stents And Keels) |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FWN clearance
Top FWN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Medical Products, Inc. | 4 | 2009-09-14 |
| Hood Laboratories | 2 | 1989-05-10 |
| E. Benson Hood Lab, Inc. | 1 | 2000-03-29 |
| Walter Lorenz Surgical, Inc. | 1 | 1990-02-22 |
| Exmoor Plastics , Ltd. | 1 | 1987-04-27 |
1 more applicants have FWN clearances. See the full list in Caduvo.
Most recent FWN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091135 | Boston Medical Products, Inc. | RUTTER SUPRA STOMAL STENTS | 2009-09-14 | 147 |
| K000154 | E. Benson Hood Lab, Inc. | ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 | 2000-03-29 | 70 |
| K962693 | Boston Medical Products, Inc. | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL | 1996-08-09 | 29 |
| K896667 | Walter Lorenz Surgical, Inc. | LORENZ STENT | 1990-02-22 | 87 |
| K884810 | Hood Laboratories | SILICONE LARYNGEAL STENT | 1989-05-10 | 174 |
Recalls for FWN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-04-22.
Frequently asked questions
What is FDA product code FWN?
FWN is the FDA product code for prosthesis, larynx (stents and keels). It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel.
What device class is FWN?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code FWN?
Across 10 cleared submissions the average was 88 days from receipt to decision (median 78).
Which companies have the most FWN clearances?
Boston Medical Products, Inc. (4); Hood Laboratories (2); E. Benson Hood Lab, Inc. (1); Walter Lorenz Surgical, Inc. (1); Exmoor Plastics , Ltd. (1).
Have FWN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-04-22.
Next steps
- Run an FDA pathway report with predicate devices for product code FWN
- Run a recall and safety report across every FWN manufacturer
- Watch product code FWN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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