DUODERM(R) HYDROACTIVE(R) PASTE— 510(k) K881302

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K881302 for DUODERM(R) HYDROACTIVE(R) PASTE, Substantially Equivalent on 1988-04-28. Applicant: Convatec, A Division of E.R. Squibb & Sons.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code FRO
Advisory panel: Unknown
Date received: 1988-03-28
Decision date: 1988-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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.