DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR— 510(k) K131511
Substantially EquivalentChangzhou Sinolinks Medical Innovation Co., Ltd.
FDA 510(k) clearance K131511 for DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR, Substantially Equivalent on 2013-07-05. Applicant: Changzhou Sinolinks Medical Innovation Co., Ltd..
Clearance details
- Applicant
- Changzhou Sinolinks Medical Innovation 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.