CLOTH-HYPOALLERGENIC— 510(k) K840947

Substantially Equivalent

Gainor Medical

FDA 510(k) clearance K840947 for CLOTH-HYPOALLERGENIC, Substantially Equivalent on 1984-08-17. Applicant: Gainor Medical.

Clearance details

Applicant: Gainor Medical
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1984-03-05
Decision date: 1984-08-17
Decision: Substantially Equivalent
Clearance type: Traditional

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.