ARGYLE COMPACT CHEST DRAINAGE SYSTEM— 510(k) K801979

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K801979 for ARGYLE COMPACT CHEST DRAINAGE SYSTEM, Substantially Equivalent on 1980-09-16. Applicant: Sherwood Medical Co..

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1980-08-19
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.