The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Single Use Ureteral Access Sheath.
| Device ID | K220065 |
| 510k Number | K220065 |
| Device Name: | Single Use Ureteral Access Sheath |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Zhejiang Chuangxiang Medical Technology Co., Ltd. Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District Hangzhou, CN 311100 |
| Contact | Lucius Long |
| Correspondent | Lucius Long Zhejiang Chuangxiang Medical Technology Co., Ltd. Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District Hangzhou, CN 311100 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-05-25 |