Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge— 510(k) K161905
Substantially EquivalentChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd
FDA 510(k) clearance K161905 for Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge, Substantially Equivalent on 2016-11-17. Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Recent devices under product code GDW
view allMore clearances from Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
view allAdverse 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.