EMOX— 510(k) K984081

Name: FDA 510(k) clearance K984081
Creator: U.S. Food and Drug Administration
Published: 1999-03-17

Substantially Equivalent

Emox 911 CC

FDA 510(k) clearance K984081 for EMOX, Substantially Equivalent on 1999-03-17. Applicant: Emox 911 CC. Device class: 2.

Clearance details

Applicant: Emox 911 CC
Product code: Code CAW
Device class: Class 2
Regulation: 21 CFR 868.5440
Advisory panel: Anesthesiology
Date received: 1998-11-16
Decision date: 1999-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset West, ZA

Download summary PDF View on FDA.gov ↗

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K984082 — BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET1999-01-28

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.