PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH— 510(k) K915358

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K915358 for PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH, Substantially Equivalent on 1992-04-28. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1991-11-27
Decision date: 1992-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Center, MN, US

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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.