K190489

Substantially Equivalent

Elcam Stopcocks and Manifolds

Applicant: Elcam Medical Acal
Product code: FMG
Advisory panel: General Hospital
Date received: 2019-02-28
Decision date: 2019-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: -, IL

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.