AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER— 510(k) K121275

Substantially Equivalent

Convatec, Inc.

FDA 510(k) clearance K121275 for AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER, Substantially Equivalent on 2012-07-25. Applicant: Convatec, Inc..

Clearance details

Applicant: Convatec, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2012-04-27
Decision date: 2012-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, US

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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.