FDA device listing
Mentor™ CPX™ 4 PLUS Enhance Breast Tissue Expanders
FDA device listing 1481002702 · MENTOR Texas, LP
Key facts
| Proprietary names | Mentor™ CPX™ 4 PLUS Enhance Breast Tissue Expanders |
|---|---|
| Owner/operator | MENTOR Texas, LP |
| Owner/operator number | 2125050 |
| Premarket submissions | K243836 |
| Product codes | LCJ |
| Device names | LCJ - Tissue Expander And Accessories |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.LCJ |
| Review panels | General & Plastic Surgery |
| Registered establishments | MENTOR, Mentor Texas LP |
| Establishment registrations | 1645337, 3005423519 |
| FEI numbers | 1000118360, 3006165545 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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