FDA product code EWQ: Saw, Surgical, Ent (Electric Or Pneumatic)
EWQ is the FDA product code for saw, surgical, ent (electric or pneumatic). It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under EWQ, from 2 different applicants. The average 510(k) review took 74 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Saw, Surgical, Ent (Electric Or Pneumatic) |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EWQ clearance
Top EWQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Laser Spectrum, Inc. | 1 | 1985-04-08 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 1980-04-21 |
Most recent EWQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844765 | Laser Spectrum, Inc. | ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN | 1985-04-08 | 122 |
| K800669 | KARL STORZ Endoscopy-America, Inc. | FELDMAN MINI-SAW, #300000 | 1980-04-21 | 26 |
Recalls for EWQ devices
openFDA lists no recalls for product code EWQ.
Frequently asked questions
What is FDA product code EWQ?
EWQ is the FDA product code for saw, surgical, ent (electric or pneumatic). It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is EWQ?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EWQ?
Across 2 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most EWQ clearances?
Laser Spectrum, Inc. (1); KARL STORZ Endoscopy-America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EWQ
- Run a recall and safety report across every EWQ manufacturer
- Watch product code EWQ 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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