510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883619Substantially Equivalent for Some Indications

Medicated Covering Coated W/1.0% Hydro Adhes. Gel

Minnetonka, Inc., Minnetonka MN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K883619 is the FDA 510(k) clearance record for MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL, cleared for Minnetonka, Inc. on under FDA product code SEK (Wound Dressings With Hydrocortisone). FDA's definition for product code SEK reads: "A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound". FDA records list 4 510(k) clearances for Minnetonka, Inc., from to . As of , FDA records show no recalls naming K883619.

Clearance record

Decision date
Received
(373 days to decision)
Product code
SEK Wound Dressings With Hydrocortisone
Device class
Unclassified
Review panel
Unknown
Applicant
Minnetonka, Inc. P.O. Box 1a, Minnetonka MN
Third party review
No

Clearances, product code SEK

Trailing 12 months

FDA records hold no clearances under product code SEK in the trailing twelve months.

FDA records show no clearances under product code SEK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260