Device Classification Name |
Endoscopic Access Overtube, Gastroenterology-Urology
|
510(k) Number |
K203165 |
Device Name |
Disposable Ureteral Access Sheath |
Applicant |
Suzhou Beyo Medical Technology Co., Ltd. |
No. 38 Beiguandu Road |
Suzhou,
CN
215000
|
|
Applicant Contact |
Aline Qin |
Correspondent |
Suzhou Beyo Medical Technology Co., Ltd. |
No. 38 Beiguandu Road |
Suzhou,
CN
215000
|
|
Correspondent Contact |
Aline Qin |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/23/2020 |
Decision Date | 04/30/2021 |
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
|
|
|