510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K984082Substantially Equivalent

Burn-Aid Hydrogel, Burn-Aid Burn Dressing, Burn-Aid Burn Blanket

Emox 911 CC, Somerset West, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984082 is the FDA 510(k) clearance record for BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET, cleared for Emox 911 CC on under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic). FDA records list 2 510(k) clearances for Emox 911 CC, from to . As of , FDA records show no recalls naming K984082.

Clearance record

Decision date
Received
(73 days to decision)
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Review panel
Unknown
Applicant
Emox 911 CC P.O. Box 79, Somerset West, ZA
510(k) summary
Statement
Third party review
No

Clearances, product code MGQ

Trailing 12 months

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

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