510(k) K123084— DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD

Substantially Equivalent

Elcam Medical Acal

Clearance details

Applicant: Elcam Medical Acal
Product code: Code FMG
Advisory panel: General Hospital
Date received: 2012-10-01
Decision date: 2013-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mp. Merom Hagalil, 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.