510(k) K220202
K220202 is an FDA 510(k) premarket notification submitted by The O R Company Pty, Ltd. for the device "Uterine ElevatOR PRO with OccludOR Balloon". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. The O R Company Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 2022
- Date Received
- January 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Manipulator/Injector, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type