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