The following data is part of a premarket notification filed by Wuxi Beien Surgery Device Co., Ltd. with the FDA for Disposable Endoscopic Staplers And Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers.
| Device ID | K211811 |
| 510k Number | K211811 |
| Device Name: | Disposable Endoscopic Staplers And Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers |
| Classification | Staple, Implantable |
| Applicant | Wuxi Beien Surgery Device Co., Ltd. No.99 Furong San Road Wuxi, CN 214192 |
| Contact | Juan Li |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-11 |
| Decision Date | 2022-03-03 |