The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Gynecare Tvt Secur System.
| Device ID | K052401 |
| 510k Number | K052401 |
| Device Name: | GYNECARE TVT SECUR SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
| Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Patricia M Hojnoski |
| Correspondent | Patricia M Hojnoski ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | PAH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-01 |
| Decision Date | 2005-11-28 |
| Summary: | summary |