K912753

Substantially Equivalent

XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL

Applicant: Xomed-Treace, Inc.
Product code: GCX
Advisory panel: General Hospital
Date received: 1991-06-24
Decision date: 1991-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.