The following data is part of a premarket notification filed by Victor Medical Instruments Co.,ltd. with the FDA for Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters And Reloads, Single Use Endoscopic Linear Cutters And Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers And Reloads.
| Device ID | K161757 |
| 510k Number | K161757 |
| Device Name: | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters And Reloads, Single Use Endoscopic Linear Cutters And Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers And Reloads |
| Classification | Staple, Implantable |
| Applicant | VICTOR MEDICAL INSTRUMENTS CO.,LTD. NO.21, HUAFENG RD, QISHUYAN DISTRICT Changzhou, CN 213018 |
| Contact | Yunhuo Chen |
| 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 | 2016-06-27 |
| Decision Date | 2016-12-05 |
| Summary: | summary |