Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K220065 |
Device Name |
Single Use Ureteral Access Sheath |
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
|
|
Applicant Contact |
Lucius Long |
Correspondent |
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
|
|
Correspondent Contact |
Lucius Long |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/10/2022 |
Decision Date | 05/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|