DUODERM CONTROL GEL FORMULA BORDER DRESSING— 510(k) K973688

Substantially Equivalent for Some Indications

Convatec, Ltd.

FDA 510(k) clearance K973688 for DUODERM CONTROL GEL FORMULA BORDER DRESSING, Substantially Equivalent for Some Indications on 1997-12-23. Applicant: Convatec, Ltd..

Clearance details

Applicant: Convatec, Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1997-09-26
Decision date: 1997-12-23
Decision: Substantially Equivalent for Some Indications
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.