The following data is part of a premarket notification filed by Zhuhai Pusen Medical Technology Co., Ltd. with the FDA for Pusen Single Use Flexible Video Cystoscope System (single Use Flexible Video Cystoscope: Pc200-as, Pc200-ar, Pc200-s And Pc200-r; Hd Medical Video Endoscope Image Processor: Pv300).
| Device ID | K222602 |
| 510k Number | K222602 |
| Device Name: | Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S And PC200-R; HD Medical Video Endoscope Image Processor: PV300) |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | Zhuhai Pusen Medical Technology Co., Ltd. 5/F, Building 1, No 33, Ke Ji San Road High-tech Zone, Tangjiawan Town Zhuhai, CN 519085 |
| Contact | Changshen Wang |
| Correspondent | Changshen Wang Zhuhai Pusen Medical Technology Co., Ltd. 5/F, Building 1, No 33, Ke Ji San Road High-tech Zone, Tangjiawan Town Zhuhai, CN 519085 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-29 |
| Decision Date | 2022-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971176280364 | K222602 | 000 |
| 06971176280357 | K222602 | 000 |
| 06971176280340 | K222602 | 000 |
| 06971176280333 | K222602 | 000 |
| 06971176280241 | K222602 | 000 |