PLEUR-EVAC A-4005 SYSTEM— 510(k) K823037

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K823037 for PLEUR-EVAC A-4005 SYSTEM, Substantially Equivalent on 1982-10-28. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1982-10-14
Decision date: 1982-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.