The following data is part of a premarket notification filed by Ethicon Inc with the FDA for Gynecare Tvt Abbrevo Continence System; Gynecare Tvt Obturator Continence System.
| Device ID | K181151 |
| 510k Number | K181151 |
| Device Name: | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System |
| Classification | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Applicant | Ethicon Inc Route 22 West Somerville, NJ 08876 |
| Contact | Debbie Fazen |
| Correspondent | Debbie Fazen Ethicon Inc Route 22 West Somerville, NJ 08876 |
| Product Code | PWJ |
| CFR Regulation Number | 884.4910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-08-10 |
| Summary: | summary |