Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)— 510(k) K143151

Substantially Equivalent

Bsn Medical GmbH

FDA 510(k) clearance K143151 for Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact), Substantially Equivalent on 2015-01-26. Applicant: Bsn Medical GmbH.

Clearance details

Applicant: Bsn Medical GmbH
Product code: Code FRO
Advisory panel: Unknown
Date received: 2014-11-03
Decision date: 2015-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

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.