The following data is part of a premarket notification filed by Ezisurg (suzhou) Medical Co., Ltd. with the FDA for Endoscopic Linear Cutting Staplers And Loading Units For Single Use.
| Device ID | K181620 |
| 510k Number | K181620 |
| Device Name: | Endoscopic Linear Cutting Staplers And Loading Units For Single Use |
| Classification | Staple, Implantable |
| Applicant | Ezisurg (Suzhou) Medical Co., Ltd. Building 16, No. 8 Jinfeng Rd., Suzhou National Hi-Tech District Suzhou, CN 215163 |
| Contact | Renjing 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 | 2018-06-20 |
| Decision Date | 2018-09-18 |
| Summary: | summary |