The following data is part of a premarket notification filed by The O R Company Pty Ltd with the FDA for Uterine Elevator Pro With Occludor Balloon.
| Device ID | K220202 |
| 510k Number | K220202 |
| Device Name: | Uterine ElevatOR PRO With OccludOR Balloon |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | The O R Company Pty Ltd 1/32 Silkwood Rise Carrum Downs, AU 3201 |
| Contact | Nicole Conway |
| Correspondent | Nicole Conway The O R Company Pty Ltd 1/32 Silkwood Rise Carrum Downs, AU 3201 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-03-31 |