Cleared Traditional

K984082 - BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET

K984082 · Emox 911 CC · General & Plastic Surgery device
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Jan 1999
Decision
73d
Days
-
Risk

K984082 is an FDA 510(k) clearance for the BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Emox 911 CC (Somerset West, ZA). The FDA issued a Cleared decision on January 28, 1999 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emox 911 CC devices

FDA 510(k) Submission Details - K984082

510(k) Number K984082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date January 28, 1999
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 65
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K984082.
MODIFICATION OF BIONECT HYDROGEL SPRAY
K984266 · Fidia Pharmaceutical Corp. · Feb 1999
MODIFICATION OF BIONECT HYDROGEL FOAM
K984267 · Fidia Pharmaceutical Corp. · Feb 1999
BIONECT HYDROGEL
K984413 · Fidia Pharmaceutical Corp. · Feb 1999
SPYROGEL HYDROGEL WOUND AND BURN DRESSING
K982804 · Innovative Technologies (Us), Inc. · Dec 1998
NU-GEL * WOUND DRESSING
K983362 · Johnson & Johnson Medical, Inc. · Dec 1998
SWEEN WOUN'DRES
K983042 · Coloplast Corp. · Nov 1998