The following data is part of a premarket notification filed by Changzhou Endoclean Medical Device Co., Ltd. with the FDA for Disposable Endoscope Valves System.
| Device ID | K221331 |
| 510k Number | K221331 |
| Device Name: | Disposable Endoscope Valves System |
| Classification | Endoscope Channel Accessory |
| Applicant | Changzhou Endoclean Medical Device Co., Ltd. West Side Of 4th Floor, Building E2, No.9 Changyang Road Changzhou, CN 213149 |
| Contact | Wang Qi |
| Correspondent | Wang Qi Changzhou Endoclean Medical Device Co., Ltd. West Side Of 4th Floor, Building E2, No.9 Changyang Road Changzhou, CN 213149 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-05 |
| Decision Date | 2022-09-08 |