THORACIC DRAINAGE SYSTEM— 510(k) K821023

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K821023 for THORACIC DRAINAGE SYSTEM, Substantially Equivalent on 1982-05-21. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1982-04-13
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.