The following data is part of a premarket notification filed by Changzhou Xin Neng Yuan Medical Stapler Co.,ltd. with the FDA for Disposable Circular Stapler For Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler And Cartridge, Disposable Linear Cutter Stapler And Stapler Cartridge.
| Device ID | K161905 |
| 510k Number | K161905 |
| Device Name: | Disposable Circular Stapler For Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler And Cartridge, Disposable Linear Cutter Stapler And Stapler Cartridge |
| Classification | Staple, Implantable |
| Applicant | CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD. NO.51, SHUISHAN RD, ZHONGLOU ECONOMIC DEVELOPMENT ZONE Changzhou, CN 213023 |
| Contact | Boping Ma |
| Correspondent | Diana Hong MID-LINK CONSULTING CO.,LTD P.O.BOX 120-119 Shanghai, CN 100102 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2016-11-17 |
| Summary: | summary |