THORA-KLEX CHEST DRAINAGE UNIT— 510(k) K905448

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K905448 for THORA-KLEX CHEST DRAINAGE UNIT, Substantially Equivalent on 1991-03-27. Applicant: Davol, Inc..

Clearance details

Applicant: Davol, Inc.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1990-12-05
Decision date: 1991-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, 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.