FDA device listing
TVT Abdominal Guides and Couplers,TVT Reusable Catheter Guide,TVT Reusable Introducer
FDA device listing 1653168984 · ETHICON INC.
Key facts
| Proprietary names | TVT Abdominal Guides and Couplers,TVT Reusable Catheter Guide,TVT Reusable Introducer |
|---|---|
| Owner/operator | ETHICON INC. |
| Owner/operator number | 2210968 |
| Premarket submissions | K173162 |
| Product codes | OTN, PWJ |
| Device names | OTN - Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, PWJ - Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.3300, 884.4910 |
| Review panels | General & Plastic Surgery, Obstetrics/Gynecology |
| Registered establishments | ETHICON SARL, GMED Healthcare BVBA ( a Johnson & Johnson Company) |
| Establishment registrations | 3003702646, 3014272734 |
| FEI numbers | 3003702646, 3014272734 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database