The following data is part of a premarket notification filed by Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. with the FDA for Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar.
| Device ID | K190029 |
| 510k Number | K190029 |
| Device Name: | Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. No. 51 Shuishan Road, 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 200120 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-07 |
| Decision Date | 2019-09-26 |
| Summary: | summary |