SURESEAL BANDAGE— 510(k) K922441

Substantially Equivalent

Gainor Medical Europe, Ltd.

FDA 510(k) clearance K922441 for SURESEAL BANDAGE, Substantially Equivalent on 1993-08-10. Applicant: Gainor Medical Europe, Ltd..

Clearance details

Applicant: Gainor Medical Europe, Ltd.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1992-05-22
Decision date: 1993-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Beach, CA, US

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.