The following data is part of a premarket notification filed by Shanghai Anqing Medical Instrument Co., Ltd. with the FDA for Ureterorenoscope System.
| Device ID | K180367 |
| 510k Number | K180367 |
| Device Name: | Ureterorenoscope System |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | Shanghai AnQing Medical Instrument CO., Ltd. 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, CN 201210 |
| Contact | Lina Fei |
| Correspondent | Lina Fei Shanghai AnQing Medical Instrument CO., Ltd. 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, CN 201210 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970034210352 | K180367 | 000 |
| 06970034210345 | K180367 | 000 |
| 06970034210147 | K180367 | 000 |
| 06970034210130 | K180367 | 000 |
| 00810116020713 | K180367 | 000 |
| 00810116020690 | K180367 | 000 |
| 00810116023004 | K180367 | 000 |