510(k) K153092
K153092 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "Ally Uterine Positioning System". The FDA issued a decision of Substantially Equivalent on December 21, 2015. 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
- December 21, 2015
- Date Received
- October 26, 2015
- 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