Device Classification Name |
instrumentation, surgical mesh, urogynecologic, stress urinary incontinence
|
510(k) Number |
K173162 |
Device Name |
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide |
Applicant |
Ethicon, Inc |
P.O. Box 151, Route 22 West |
Somerville,
NJ
08876
|
|
Applicant Contact |
Julie Tom Wing |
Correspondent |
Ethicon, Inc |
P.O. Box 151, Route 22 West |
Somerville,
NJ
08876
|
|
Correspondent Contact |
Julie Tom Wing |
Regulation Number | 884.4910
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 06/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|