Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K231725 |
Device Name |
Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) |
Applicant |
Hunan Endoso Life Technology Co., Ltd. |
4th floor, Building 10, Innovation and Entrepreneurship |
Center, 31 Dongfeng Road, Heping Street, Xiangtan Economic D |
HuNan,
CN
411199
|
|
Applicant Contact |
Fu Wang |
Correspondent |
Hunan Endoso Life Technology Co., Ltd. |
4th floor, Building 10, Innovation and Entrepreneurship |
Center, 31 Dongfeng Road, Heping Street, Xiangtan Economic D |
HuNan,
CN
411199
|
|
Correspondent Contact |
Fu Wang |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/13/2023 |
Decision Date | 10/16/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|