MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)— 510(k) K080878

Substantially Equivalent

Medical Technologies of Georgia, Inc.

FDA 510(k) clearance K080878 for MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT), Substantially Equivalent on 2008-07-17. Applicant: Medical Technologies of Georgia, Inc..

Clearance details

Applicant: Medical Technologies of Georgia, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2008-03-31
Decision date: 2008-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

Download summary PDF View 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, 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.