FDA product code EXW: Pill, Radio
EXW is the FDA product code for pill, radio. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under EXW. The average 510(k) review took 115 days (median 115).
Classification
| Field | Value |
|---|---|
| Device name | Pill, Radio |
| Device class | Class II |
| Regulation | 21 CFR 876.1725 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Top EXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oxford Medilog, Inc. | 1 | 1984-06-28 |
Most recent EXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840934 | Oxford Medilog, Inc. | MEDILOG PH1 | 1984-06-28 | 115 |
Recalls for EXW devices
openFDA lists no recalls for product code EXW.
Frequently asked questions
What is FDA product code EXW?
EXW is the FDA product code for pill, radio. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel.
What device class is EXW?
Class II, regulation 21 CFR 876.1725. Typical premarket route: 510(k).
How long does a 510(k) take for product code EXW?
Across 1 cleared submissions the average was 115 days from receipt to decision (median 115).
Which companies have the most EXW clearances?
Oxford Medilog, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EXW
- Run a recall and safety report across every EXW manufacturer
- Watch product code EXW 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 Gastroenterology and Urology product codes · FDA product code lookup