The following data is part of a premarket notification filed by Ezisurg Medical Co., Ltd. with the FDA for Easyendotm Linear Cutting Stapler And Loading Units For Single Use, Easyendotm Universal Linear Cutting Stapler And Loading Units For Single Use.
| Device ID | K172960 |
| 510k Number | K172960 |
| Device Name: | EasyEndoTM Linear Cutting Stapler And Loading Units For Single Use, EasyEndoTM Universal Linear Cutting Stapler And Loading Units For Single Use |
| Classification | Staple, Implantable |
| Applicant | Ezisurg Medical Co., Ltd. Rm. 103, Bldg.2, No.1690 Cailun Road China (Shanghai) Pilot Free Trade Zone Shanghai, CN 201203 |
| Contact | Sheng Tian |
| 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 | 2017-09-26 |
| Decision Date | 2017-12-21 |
| Summary: | summary |