FDA product code EPW: Support, Head, Surgical, Ent
EPW is the FDA product code for support, head, surgical, ent. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under EPW, from 2 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Support, Head, Surgical, Ent |
| Device class | Class I |
| Regulation | 21 CFR 878.4950 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EPW clearance
Top EPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Life, Inc. | 1 | 1982-06-07 |
| The Anspach Effort, Inc. | 1 | 1980-06-26 |
Most recent EPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821306 | Med-Life, Inc. | HEAD-UP SUPINE SAFETY SUPPORT CUSHION | 1982-06-07 | 34 |
| K801326 | The Anspach Effort, Inc. | ANSPACH OPERATING TABLE SUPPORT/SPINAL | 1980-06-26 | 23 |
Recalls for EPW devices
openFDA lists no recalls for product code EPW.
Frequently asked questions
What is FDA product code EPW?
EPW is the FDA product code for support, head, surgical, ent. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel.
What device class is EPW?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EPW?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most EPW clearances?
Med-Life, Inc. (1); The Anspach Effort, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EPW
- Run a recall and safety report across every EPW manufacturer
- Watch product code EPW 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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