The following data is part of a premarket notification filed by Fengh Medical Co., Ltd. with the FDA for Disposable Endoscopic Trocar.
| Device ID | K180208 |
| 510k Number | K180208 |
| Device Name: | Disposable Endoscopic Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Fengh Medical Co., Ltd. D3 No. 6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, CN 214437 |
| Contact | Jun Zhou |
| Correspondent | Jun Zhou Fengh Medical Co., Ltd. D3 No. 6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, CN 214437 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-04-09 |
| Summary: | summary |