The following data is part of a premarket notification filed by Zhuhai Pusen Medical Technology Co., Ltd. with the FDA for Medical Video Endoscope System.
| Device ID | K172098 |
| 510k Number | K172098 |
| Device Name: | Medical Video Endoscope System |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Zhuhai Pusen Medical Technology Co., Ltd. 5/F, Building 1, No 33, Keji San Road High-tech Zone,Tangjiawan Town Zhuhai, CN 519085 |
| Contact | Wang Changshen |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-07-11 |
| Decision Date | 2017-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971176280111 | K172098 | 000 |
| 16971176280026 | K172098 | 000 |
| 16971176280019 | K172098 | 000 |
| 16971176280002 | K172098 | 000 |
| 16971176280439 | K172098 | 000 |
| 16971176280422 | K172098 | 000 |
| 16971176280415 | K172098 | 000 |