The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Gynecare Tvt™ System, Gynecare Tvt™ With Abdominal Guides System, Gynecare Tvt™ Introducer And Catheter Guide, Gynecare Tvt Exact™ Continence System And Trocar, Gynecare Tvt™ Obturator System And Passers And Winged Guide, Gynecare Tvt Abbrevo™ Contin.
| Device ID | K201686 |
| 510k Number | K201686 |
| Device Name: | GYNECARE TVT™ System, GYNECARE TVT™ With Abdominal Guides System, GYNECARE TVT™ Introducer And Catheter Guide, GYNECARE TVT EXACT™ Continence System And Trocar, GYNECARE TVT™ Obturator System And Passers And Winged Guide, GYNECARE TVT ABBREVO™ Contin |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | Ethicon Inc. Route 22 West Somerville, NJ 08876 -0151 |
| Contact | Ariell Joiner |
| Correspondent | Ariell Joiner Ethicon Inc. Route 22 West Somerville, NJ 08876 -0151 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2020-09-17 |