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 |