XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL— 510(k) K912753

Substantially Equivalent

Xomed-Treace, Inc.

FDA 510(k) clearance K912753 for XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL, Substantially Equivalent on 1991-09-23. Applicant: Xomed-Treace, Inc..

Clearance details

Applicant: Xomed-Treace, Inc.
Product code: 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

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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.