FDA device listing
Restorelle M,Restorelle XL
FDA device listing 1417177546 · Coloplast Corp.
Key facts
| Proprietary names | Restorelle M,Restorelle XL |
|---|---|
| Owner/operator | Coloplast Corp. |
| Owner/operator number | 8010144 |
| Premarket submissions | K132061 |
| Product codes | OTO |
| Device names | OTO - Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.3300 |
| Review panels | General & Plastic Surgery |
| Registered establishments | COLOPLAST MANUFACTURING US, LLC |
| Establishment registrations | 2125050 |
| FEI numbers | 2125050 |
| Establishment operations | Specification Developer |
| 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