ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS— 510(k) K130738
Substantially EquivalentNanjing Maidixin Medical Device Co., Ltd.
FDA 510(k) clearance K130738 for ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS, Substantially Equivalent on 2013-12-13. Applicant: Nanjing Maidixin Medical Device Co., Ltd..
Clearance details
- Applicant
- Nanjing Maidixin Medical Device Co., Ltd.
- Product code
- Code GDW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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.