FDA product code EWG: Laser, Ent Microsurgical Carbon-Dioxide
EWG is the FDA product code for laser, ent microsurgical carbon-dioxide. It is a Class II device, regulated under 21 CFR 874.4500 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 24 510(k) submissions under EWG, from 14 different applicants. The average 510(k) review took 123 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Laser, Ent Microsurgical Carbon-Dioxide |
| Device class | Class II |
| Regulation | 21 CFR 874.4500 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every EWG clearance
Top EWG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Directed Energy, Inc. | 5 | 1987-09-24 |
| Cooper Lasersonics, Inc. | 3 | 1988-04-18 |
| Laserscope | 2 | 1987-02-25 |
| Britt Corp., Inc. | 2 | 1986-07-18 |
| Minnesota Laser Corp. | 2 | 1986-02-13 |
9 more applicants have EWG clearances. See the full list in Caduvo.
Most recent EWG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924652 | Benson Medical Instruments Co. | BENSON CCA100 | 1993-04-09 | 206 |
| K870587 | Lasermatic OY | LASERMATIC SURGILASER MODEL 5050 | 1988-08-10 | 547 |
| K880428 | Cooper Lasersonics, Inc. | ILLUMINA 25 CO2 LASER SYSTEM | 1988-04-18 | 77 |
| K880429 | Cooper Lasersonics, Inc. | ILLUMINA 55 CO2 LASER SYSTEM | 1988-04-18 | 77 |
| K880427 | Cooper Lasersonics, Inc. | ILLUMINA 40 CO2 LASER SYSTEM | 1988-04-18 | 77 |
Recalls for EWG devices
openFDA lists no recalls for product code EWG.
Frequently asked questions
What is FDA product code EWG?
EWG is the FDA product code for laser, ent microsurgical carbon-dioxide. It is a Class II device, regulated under 21 CFR 874.4500 and reviewed by the Ear, Nose and Throat panel.
What device class is EWG?
Class II, regulation 21 CFR 874.4500. Typical premarket route: 510(k).
How long does a 510(k) take for product code EWG?
Across 24 cleared submissions the average was 123 days from receipt to decision (median 96).
Which companies have the most EWG clearances?
Directed Energy, Inc. (5); Cooper Lasersonics, Inc. (3); Laserscope (2); Britt Corp., Inc. (2); Minnesota Laser Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code EWG
- Run a recall and safety report across every EWG manufacturer
- Watch product code EWG 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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