Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K210104 |
Device Name |
SurroundScope System |
Applicant |
270Surgical Ltd. |
4 Arie Regev Street |
Netanya,
IL
4250212
|
|
Applicant Contact |
Avi Levy |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street |
Suite 2300 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice Hogan |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 01/14/2021 |
Decision Date | 07/08/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|