FDA product code EGW: Dryer, Film, Radiographic
EGW is the FDA product code for dryer, film, radiographic. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under EGW, from 2 different applicants. The average 510(k) review took 61 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Dryer, Film, Radiographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EGW clearance
Top EGW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| G-C Intl. Corp. | 1 | 1990-07-13 |
| Pako Corp. | 1 | 1977-01-07 |
Most recent EGW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902531 | G-C Intl. Corp. | EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL | 1990-07-13 | 38 |
| K760846 | Pako Corp. | PAKOSTAT II | 1977-01-07 | 84 |
Recalls for EGW devices
openFDA lists no recalls for product code EGW.
Frequently asked questions
What is FDA product code EGW?
EGW is the FDA product code for dryer, film, radiographic. It is a Class II device, regulated under 21 CFR 892.1900 and reviewed by the Radiology panel.
What device class is EGW?
Class II, regulation 21 CFR 892.1900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EGW?
Across 2 cleared submissions the average was 61 days from receipt to decision (median 61).
Which companies have the most EGW clearances?
G-C Intl. Corp. (1); Pako Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EGW
- Run a recall and safety report across every EGW manufacturer
- Watch product code EGW 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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