The following data is part of a premarket notification filed by Tgs Medical Co., Ltd. with the FDA for Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler And Reload, Single Patient Use Linear Cutter And Reload, Single Patient Use Endo Cutter And Reload, Single Patient Use Transverse Cutter And Relo.
| Device ID | K162710 |
| 510k Number | K162710 |
| Device Name: | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler And Reload, Single Patient Use Linear Cutter And Reload, Single Patient Use Endo Cutter And Reload, Single Patient Use Transverse Cutter And Relo |
| Classification | Staple, Implantable |
| Applicant | TGS Medical Co., Ltd. Building 17, No.8 Jinfeng Road, High-tech Zone Suzhou, CN 214163 |
| Contact | Hua Cao |
| 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 | 2016-09-28 |
| Decision Date | 2017-02-09 |
| Summary: | summary |