K161905 is an FDA 510(k) clearance for the 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. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on November 17, 2016, 129 days after receiving the submission on July 11, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K161905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2016 |
| Decision Date | November 17, 2016 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW - Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |