STATIM 2000 G4 CASSETTE— 510(k) K112872

Substantially Equivalent

Scican , Ltd.

FDA 510(k) clearance K112872 for STATIM 2000 G4 CASSETTE, Substantially Equivalent on 2012-07-10. Applicant: Scican , Ltd..

Clearance details

Applicant: Scican , Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2011-09-30
Decision date: 2012-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.