FDA product code EYF: Protector, Wound, Plastic
EYF is the FDA product code for protector, wound, plastic. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under EYF, from 5 different applicants. The average 510(k) review took 103 days (median 99).
Classification
| Field | Value |
|---|---|
| Device name | Protector, Wound, Plastic |
| Device class | Class I |
| Regulation | 21 CFR 878.4014 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every EYF clearance
Top EYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Autovage | 1 | 1992-10-16 |
| Harding Medical Devices | 1 | 1991-07-05 |
| Central Plastic, Inc. | 1 | 1991-04-12 |
| David F. Trungale | 1 | 1990-12-17 |
| Coloplast A/S | 1 | 1983-12-12 |
Most recent EYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922785 | Autovage | IRRIVAGE | 1992-10-16 | 129 |
| K911407 | Harding Medical Devices | HARDING STERNAL SHIELD | 1991-07-05 | 98 |
| K910104 | Central Plastic, Inc. | ANTI-FOG DISPOSABLE IV INDUCTION COVER | 1991-04-12 | 99 |
| K904389 | David F. Trungale | SI-PRO | 1990-12-17 | 82 |
| K832908 | Coloplast A/S | COMFEEL PROTECTIVE RINGS | 1983-12-12 | 105 |
Recalls for EYF devices
openFDA lists no recalls for product code EYF.
Frequently asked questions
What is FDA product code EYF?
EYF is the FDA product code for protector, wound, plastic. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General and Plastic Surgery panel.
What device class is EYF?
Class I, regulation 21 CFR 878.4014. Typical premarket route: 510(k).
How long does a 510(k) take for product code EYF?
Across 5 cleared submissions the average was 103 days from receipt to decision (median 99).
Which companies have the most EYF clearances?
Autovage (1); Harding Medical Devices (1); Central Plastic, Inc. (1); David F. Trungale (1); Coloplast A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EYF
- Run a recall and safety report across every EYF manufacturer
- Watch product code EYF 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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