FDA product code ENW: Catheter, Nasopharyngeal
ENW is the FDA product code for catheter, nasopharyngeal. It is a Class I device, regulated under 21 CFR 874.4175 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under ENW, from 2 different applicants. The average 510(k) review took 113 days (median 113).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Nasopharyngeal |
| Device class | Class I |
| Regulation | 21 CFR 874.4175 |
| 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 ENW clearance
Top ENW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American V. Mueller | 1 | 1985-07-22 |
| Axiom Medical, Inc. | 1 | 1983-11-03 |
Most recent ENW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851082 | American V. Mueller | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | 1985-07-22 | 126 |
| K832476 | Axiom Medical, Inc. | SILICONE SOFT-PAK EPISTAXIS CATHETER | 1983-11-03 | 100 |
Recalls for ENW devices
openFDA lists no recalls for product code ENW.
Frequently asked questions
What is FDA product code ENW?
ENW is the FDA product code for catheter, nasopharyngeal. It is a Class I device, regulated under 21 CFR 874.4175 and reviewed by the Ear, Nose and Throat panel.
What device class is ENW?
Class I, regulation 21 CFR 874.4175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ENW?
Across 2 cleared submissions the average was 113 days from receipt to decision (median 113).
Which companies have the most ENW clearances?
American V. Mueller (1); Axiom Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ENW
- Run a recall and safety report across every ENW manufacturer
- Watch product code ENW 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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