Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K230748 |
Device Name |
Disposable Ureteral Access Sheath |
Applicant |
YouCare Technology Co., Ltd. (Wuhan) |
Tangxunhu North Street |
Wuhan,
CN
430000
|
|
Applicant Contact |
Bing Hu |
Correspondent |
YouCare Technology Co., Ltd. (Wuhan) |
Tangxunhu North Street |
Wuhan,
CN
430000
|
|
Correspondent Contact |
Bing Hu |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/17/2023 |
Decision Date | 08/02/2023 |
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
|
|
|