FDA device listing
PS3111,Uterine Manipulator - Various names and models
FDA device listing 1882512520 · Purple Surgical International Limited
Key facts
| Proprietary names | PS3111,Uterine Manipulator - Various names and models |
|---|---|
| Owner/operator | Purple Surgical International Limited |
| Owner/operator number | 10033672 |
| Premarket submissions | K022503 |
| Product codes | LKF |
| Device names | LKF - Cannula, Manipulator/Injector, Uterine |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.4530 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | PURPLE SURGICAL INTERNATIONAL LIMITED, Purple Surgical Manufacturing Limited |
| Establishment registrations | 3008439467, 3008571754 |
| FEI numbers | 3008439467, 3008571754 |
| Establishment operations | Contract Manufacturer, Repackager/Relabeler |
| 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