Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K231042 |
Device Name |
Disposable Laparoscopic Trocar |
Applicant |
Changzhou Ankang Medical Instruments Co., Ltd. |
A4 Standard Workshop, Hutang Science and Technology |
Industrial Park, Hutang Town, Wujin District |
Changzhou,
CN
213162
|
|
Applicant Contact |
Tingting Cao |
Correspondent |
Mid-Link Consulting Co.,Ltd |
P.O.BOX 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/12/2023 |
Decision Date | 06/08/2023 |
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
|
|
|