Device Classification Name |
mesh, surgical, for stress urinary incontinence, male
|
510(k) Number |
K231891 |
Device Name |
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit |
Applicant |
Coloplast |
1601 West River Road North |
Minneapolis,
MN
55411
|
|
Applicant Contact |
Jennifer Mrkvicka |
Correspondent |
Coloplast |
1601 West River Road North |
Minneapolis,
MN
55411
|
|
Correspondent Contact |
Jennifer Mrkvicka |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/27/2023 |
Decision Date | 09/25/2023 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|