510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SEKUnclassified

Wound Dressings With Hydrocortisone

Unknown
FDA source (opens on fda.gov)

SEK is the FDA product code for Wound Dressings With Hydrocortisone. FDA's definition for this code reads: "A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SEK
Device name
Wound Dressings With Hydrocortisone
FDA definition
A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SEK

By decision year
2 clearances under product code SEK with a decision year between 1989 and 1989, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SEK by decision year
YearClearances
19892

Applicants with the most clearances

Product code SEK
Applicants holding the most 510(k) clearances under product code SEK
ApplicantClearances
Minnetonka, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SEK.