FDA product code EWL: Prosthesis, Laryngeal (Taub)
EWL is the FDA product code for prosthesis, laryngeal (taub). It is a Class II device, regulated under 21 CFR 874.3730 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 40 510(k) submissions under EWL, 1 in the last five years, from 14 different applicants. The average 510(k) review took 112 days (median 82); 273 days on average over the last three years. FDA has posted 4 recalls for EWL devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Laryngeal (Taub) |
| Device class | Class II |
| Regulation | 21 CFR 874.3730 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for EWL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 273 |
Compare with all 510(k) review times · Search every EWL clearance
Top EWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helix Medical, Inc. | 10 | 1999-06-25 |
| Atos Medical AB | 8 | 2014-09-26 |
| Bivona Medical Technologies | 8 | 1992-06-29 |
| Helix Medical, LLC | 2 | 2010-03-03 |
| Hood Laboratories | 2 | 1986-03-12 |
9 more applicants have EWL clearances. See the full list in Caduvo.
Most recent EWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240763 | Freudenberg Medical, LLC | FirstFit Surgical Kit | 2024-12-18 | 273 |
| K141380 | Atos Medical AB | PROVOX FREEHANDS FLEXIVOICE | 2014-09-26 | 122 |
| K131947 | Atos Medical AB | PROVOX VEGA PUNCTURE SET | 2013-10-18 | 113 |
| K092593 | Atos Medical AB | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | 2010-10-14 | 416 |
| K093258 | Helix Medical, LLC | BLOM-SINGER INDWELLING TEP OCCLUDER | 2010-03-03 | 135 |
Recalls for EWL devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-06-17.
| Year | Recalls |
|---|---|
| 2026 | 2 |
Frequently asked questions
What is FDA product code EWL?
EWL is the FDA product code for prosthesis, laryngeal (taub). It is a Class II device, regulated under 21 CFR 874.3730 and reviewed by the Ear, Nose and Throat panel.
What device class is EWL?
Class II, regulation 21 CFR 874.3730. Typical premarket route: 510(k).
How long does a 510(k) take for product code EWL?
Across 40 cleared submissions the average was 112 days from receipt to decision (median 82).
Which companies have the most EWL clearances?
Helix Medical, Inc. (10); Atos Medical AB (8); Bivona Medical Technologies (8); Helix Medical, LLC (2); Hood Laboratories (2).
Have EWL devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2026-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code EWL
- Run a recall and safety report across every EWL manufacturer
- Watch product code EWL 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.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times