VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS— 510(k) K891133

Substantially Equivalent

Elwyn, Inc.

FDA 510(k) clearance K891133 for VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS, Substantially Equivalent on 1989-05-24. Applicant: Elwyn, Inc..

Clearance details

Applicant: Elwyn, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1989-03-03
Decision date: 1989-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elwyn, PA, 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.