The following data is part of a premarket notification filed by Fengh Medical Co., Ltd. with the FDA for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads.
| Device ID | K182476 |
| 510k Number | K182476 |
| Device Name: | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads |
| Classification | Staple, Implantable |
| Applicant | Fengh Medical Co., Ltd. D3 No.6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, CN 214437 |
| Contact | Jiao Liu |
| Correspondent | Jiao Liu Fengh Medical Co., Ltd. D3 No.6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, CN 214437 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2019-12-18 |