AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING— 510(k) K100693

Substantially Equivalent

Medtrade Products Limited

FDA 510(k) clearance K100693 for AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING, Substantially Equivalent on 2010-08-10. Applicant: Medtrade Products Limited.

Clearance details

Applicant: Medtrade Products Limited
Product code: Code FRO
Advisory panel: Unknown
Date received: 2010-03-11
Decision date: 2010-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crewe, Cheshire, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.