FDA product code SEK: Wound Dressings With Hydrocortisone
SEK is the FDA product code for wound dressings with hydrocortisone. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under SEK. The average 510(k) review took 374 days (median 374).
Definition
A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound
Classification
| Field | Value |
|---|---|
| Device name | Wound Dressings With Hydrocortisone |
| 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 SEK clearance
Top SEK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Minnetonka, Inc. | 2 | 1989-09-01 |
Most recent SEK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883566 | Minnetonka, Inc. | MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL | 1989-09-01 | 375 |
| K883619 | Minnetonka, Inc. | MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL | 1989-09-01 | 373 |
Recalls for SEK devices
openFDA lists no recalls for product code SEK.
Frequently asked questions
What is FDA product code SEK?
SEK is the FDA product code for wound dressings with hydrocortisone. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is SEK?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEK?
Across 2 cleared submissions the average was 374 days from receipt to decision (median 374).
Which companies have the most SEK clearances?
Minnetonka, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code SEK
- Run a recall and safety report across every SEK manufacturer
- Watch product code SEK 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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