The following data is part of a premarket notification filed by Shanghai Anqing Medical Instrument Co., Ltd. with the FDA for Flexible Ureterorenoscope (model: Us31e-12-eu, Us31e-12-us).
| Device ID | K222737 |
| 510k Number | K222737 |
| Device Name: | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Shanghai AnQing Medical Instrument Co., Ltd. 3 & 4 Floor, No.2 Building, 366 Huiqing Rd East Zhangjiang High-Tech Park Shanghai, CN 201201 |
| Contact | Shuwen Fan |
| Correspondent | Shuwen Fan Shanghai AnQing Medical Instrument Co., Ltd. 3 & 4 Floor, No.2 Building, 366 Huiqing Rd East Zhangjiang High-Tech Park Shanghai, CN 201201 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-09 |
| Decision Date | 2022-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970034210635 | K222737 | 000 |
| 06970034210628 | K222737 | 000 |