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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936534303956 | K220065 | 000 |
| 06936534304120 | K220065 | 000 |
| 06936534304113 | K220065 | 000 |
| 06936534304106 | K220065 | 000 |
| 06936534304090 | K220065 | 000 |
| 06936534304083 | K220065 | 000 |
| 06936534304076 | K220065 | 000 |
| 06936534304069 | K220065 | 000 |
| 06936534304052 | K220065 | 000 |
| 06936534304045 | K220065 | 000 |
| 06936534304038 | K220065 | 000 |
| 06936534304021 | K220065 | 000 |
| 06936534304014 | K220065 | 000 |
| 06936534304007 | K220065 | 000 |
| 06936534303994 | K220065 | 000 |
| 06936534303987 | K220065 | 000 |
| 06936534304137 | K220065 | 000 |
| 06936534304144 | K220065 | 000 |
| 06936534304151 | K220065 | 000 |
| 06936534303949 | K220065 | 000 |
| 06936534303932 | K220065 | 000 |
| 06936534303925 | K220065 | 000 |
| 06936534303918 | K220065 | 000 |
| 06936534304267 | K220065 | 000 |
| 06936534304250 | K220065 | 000 |
| 06936534304243 | K220065 | 000 |
| 06936534304236 | K220065 | 000 |
| 06936534304229 | K220065 | 000 |
| 06936534304212 | K220065 | 000 |
| 06936534304205 | K220065 | 000 |
| 06936534304199 | K220065 | 000 |
| 06936534304182 | K220065 | 000 |
| 06936534304175 | K220065 | 000 |
| 06936534304168 | K220065 | 000 |
| 06936534303970 | K220065 | 000 |