SICAT OPTIMOTION— 510(k) K143655

Substantially Equivalent

Sicat GmbH & Co. KG

FDA 510(k) clearance K143655 for SICAT OPTIMOTION, Substantially Equivalent on 2015-10-02. Applicant: Sicat GmbH & Co. KG.

Clearance details

Applicant: Sicat GmbH & Co. KG
Product code: Code MQC
Advisory panel: Unknown
Date received: 2014-12-23
Decision date: 2015-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonn, DE

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Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.