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

Name: FDA 510(k) clearance K143151
Creator: U.S. Food and Drug Administration
Published: 2015-01-26

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. Device class: Unclassified.

Clearance details

Applicant: Bsn Medical GmbH
Product code: Code FRO
Device class: Unclassified
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 ↗

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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.