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.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Technology, Inc.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code KNT
view allMore clearances from Applied Medical Technology, Inc.
view allAdverse 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 →
Recalls naming K073034
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073034.
Data sourced from openFDA. This site is unofficial and independent of the FDA.