SIGNALDRESS— 510(k) K962590

Substantially Equivalent for Some Indications

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

FDA 510(k) clearance K962590 for SIGNALDRESS, Substantially Equivalent for Some Indications on 1996-09-20. 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: 1996-07-02
Decision date: 1996-09-20
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.