FDA product code SEJ: Wound Dressings Containing Topical Analgesics
SEJ is the FDA product code for wound dressings containing topical analgesics. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under SEJ, from 6 different applicants. The average 510(k) review took 196 days (median 185).
Definition
A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.
Classification
| Field | Value |
|---|---|
| Device name | Wound Dressings Containing Topical Analgesics |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every SEJ clearance
Top SEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amerx Health Care Corp. | 1 | 2009-07-30 |
| At Squared, LLC | 1 | 2006-06-26 |
| Mpm Medical., Inc. | 1 | 2002-11-01 |
| Johnson & Johnson Consumer Companies, Inc. | 1 | 2000-09-22 |
| Mckinley-Ross Laboratories, Inc. | 1 | 1992-11-09 |
1 more applicants have SEJ clearances. See the full list in Caduvo.
Most recent SEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092086 | Amerx Health Care Corp. | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 | 2009-07-30 | 21 |
| K053476 | At Squared, LLC | ALLWOUND | 2006-06-26 | 194 |
| K020540 | Mpm Medical., Inc. | REGENECARE WOUND GEL | 2002-11-01 | 255 |
| K001023 | Johnson & Johnson Consumer Companies, Inc. | FREEDOM, MODEL 4660 | 2000-09-22 | 176 |
| K922636 | Mckinley-Ross Laboratories, Inc. | HEMO-STAT | 1992-11-09 | 164 |
Recalls for SEJ devices
openFDA lists no recalls for product code SEJ.
Frequently asked questions
What is FDA product code SEJ?
SEJ is the FDA product code for wound dressings containing topical analgesics. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is SEJ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEJ?
Across 6 cleared submissions the average was 196 days from receipt to decision (median 185).
Which companies have the most SEJ clearances?
Amerx Health Care Corp. (1); At Squared, LLC (1); Mpm Medical., Inc. (1); Johnson & Johnson Consumer Companies, Inc. (1); Mckinley-Ross Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SEJ
- Run a recall and safety report across every SEJ manufacturer
- Watch product code SEJ 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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