The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd. with the FDA for Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler And Reloads, Disposable Linear Cutter Stapler And Reloads, Disposable Endoscopic Linear Cutter Stapler And Reloads.
| Device ID | K201639 |
| 510k Number | K201639 |
| Device Name: | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler And Reloads, Disposable Linear Cutter Stapler And Reloads, Disposable Endoscopic Linear Cutter Stapler And Reloads |
| Classification | Staple, Implantable |
| Applicant | Beijing Biosis Healing Biological Technology Co., Ltd. Valley No.1 Bio-medicine Industry Park, Daxing District Beijing, CN 102600 |
| Contact | Ting Jiang |
| 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 | 2020-06-16 |
| Decision Date | 2021-05-27 |