Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K212786 |
Device Name |
LevaLap Laparoscopic Access Device |
Applicant |
Core Access Surgical Technologies, Inc. |
3495 Piedmont Road, NE Building 11, Suite 905 |
Atlanta,
GA
30305
|
|
Applicant Contact |
Marianne D. Jacklyn |
Correspondent |
Core Access Surgical Technologies, Inc. |
3495 Piedmont Road, NE Building 11, Suite 905 |
Atlanta,
GA
30305
|
|
Correspondent Contact |
Marianne D. Jacklyn |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 09/01/2021 |
Decision Date | 02/23/2022 |
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
|
|
|