510(k) K223064
K223064 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "ALLY II Uterine Positioning System (UPS)". The FDA issued a decision of Substantially Equivalent on October 28, 2022. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2022
- Date Received
- September 30, 2022
- Clearance Type
- Special
- 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