AMT G-J TUBE— 510(k) K110804
UnknownApplied Medical Technology, Inc.
FDA 510(k) clearance K110804 for AMT G-J TUBE, Unknown on 2011-10-19. 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
- Brecksville, 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 K110804
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 K110804.
Data sourced from openFDA. This site is unofficial and independent of the FDA.