The following data is part of a premarket notification filed by Changzhou Kangdi Medical Stapler Co., Ltd. with the FDA for Disposable Circular Stapler.
| Device ID | K172561 |
| 510k Number | K172561 |
| Device Name: | Disposable Circular Stapler |
| Classification | Staple, Implantable |
| Applicant | Changzhou Kangdi Medical Stapler Co., Ltd. No.16 Kunlun Road, XinBei Zone Changzhou City, CN 213022 |
| Contact | Eve Zhou |
| Correspondent | Charlie Mack IRC 2091 Oak Drive Lake Havasu City, AZ 86406 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-25 |
| Decision Date | 2017-12-05 |
| Summary: | summary |