K915358

Substantially Equivalent

PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH

Applicant: Medtronic Vascular
Product 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

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.