K211811 is an FDA 510(k) clearance for the Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Wuxi Beien Surgery Device Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on March 3, 2022, 265 days after receiving the submission on June 11, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K211811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2021 |
| Decision Date | March 03, 2022 |
| Days to Decision | 265 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 |