SICAT FUNCTION— 510(k) K133320

Substantially Equivalent

Sicat GmbH & Co. KG

FDA 510(k) clearance K133320 for SICAT FUNCTION, Substantially Equivalent on 2014-02-25. Applicant: Sicat GmbH & Co. KG.

Clearance details

Applicant: Sicat GmbH & Co. KG
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-10-28
Decision date: 2014-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonn, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.