MMG FOLEY CATHETER— 510(k) K840839

Substantially Equivalent

Medical Technologies of Georgia

FDA 510(k) clearance K840839 for MMG FOLEY CATHETER, Substantially Equivalent on 1984-04-17. Applicant: Medical Technologies of Georgia.

Clearance details

Applicant
Medical Technologies of Georgia
Product code
Code KOD
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KOD

product code KOD
Death
5
Injury
1,129
Malfunction
7,019
Total
8,153

Source: openFDA MAUDE database, through . 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.