The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Gynecare Tvt Reusable Introducer, Gynecare Tvt Reusable Rigid Catheter Guide, Gynecare Tvt Exact Continence System Trocar.
| Device ID | K173019 |
| 510k Number | K173019 |
| Device Name: | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar |
| Classification | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Applicant | Ethicon Inc. Route 22 West Somerville, NJ 08876 -0151 |
| Contact | Melina Escobar |
| Correspondent | Melina Escobar Ethicon Inc. Route 22 West Somerville, NJ 08876 -0151 |
| Product Code | PWJ |
| CFR Regulation Number | 884.4910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-07-06 |
| Summary: | summary |