AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)— 510(k) K073034

Unknown

Applied Medical Technology, Inc.

FDA 510(k) clearance K073034 for AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419), Unknown on 2008-03-14. Applicant: Applied Medical Technology, Inc..

Clearance details

Applicant
Applied Medical Technology, Inc.
Product code
Code KNT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Cleveland, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNT

product code KNT
Death
192
Injury
6,034
Malfunction
4,049
Other
1
Total
10,276

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.