510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K955476Substantially Equivalent for Some Indications

Dukal Transparent Wound Dressing

Dukal Corp., Palm Harobor FL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K955476 is the FDA 510(k) clearance record for DUKAL TRANSPARENT WOUND DRESSING, cleared for Dukal Corp. on under FDA product code MGP (Dressing, Wound And Burn, Occlusive). FDA records list one 510(k) clearance for Dukal Corp. As of , FDA records show no recalls naming K955476.

Clearance record

Decision date
Received
(49 days to decision)
Product code
MGP Dressing, Wound And Burn, Occlusive
Device class
Unclassified
Review panel
Unknown
Applicant
Dukal Corp. 1247 Florida Ave., Palm Harobor FL
Third party review
No

Clearances, product code MGP

Trailing 12 months

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

FDA records show no clearances under product code MGP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGP, 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