The following data is part of a premarket notification filed by Hunan Vathin Medical Instrument Co., Ltd. with the FDA for Single-use Flexible Cystoscope.
| Device ID | K221580 |
| 510k Number | K221580 |
| Device Name: | Single-Use Flexible Cystoscope |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, CN 411100 |
| Contact | Du Jing |
| Correspondent | Du Jing Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, CN 411100 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-01 |
| Decision Date | 2022-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972197480474 | K221580 | 000 |
| 06972197483208 | K221580 | 000 |
| 06972197483192 | K221580 | 000 |
| 06972197483185 | K221580 | 000 |
| 06972197483178 | K221580 | 000 |
| 06972197483109 | K221580 | 000 |
| 06972197483093 | K221580 | 000 |
| 06972197483086 | K221580 | 000 |
| 06972197483079 | K221580 | 000 |
| 06972197483215 | K221580 | 000 |
| 06972197480368 | K221580 | 000 |
| 06972197480450 | K221580 | 000 |
| 06972197480443 | K221580 | 000 |
| 06972197480436 | K221580 | 000 |
| 06972197480429 | K221580 | 000 |
| 06972197480412 | K221580 | 000 |
| 06972197480399 | K221580 | 000 |
| 06972197480382 | K221580 | 000 |
| 06972197480375 | K221580 | 000 |
| 06972197483062 | K221580 | 000 |