The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Ally Ii Uterine Positioning System™ (ups).
| Device ID | K223064 |
| 510k Number | K223064 |
| Device Name: | ALLY II Uterine Positioning System™ (UPS) |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Contact | Yin Huang |
| Correspondent | Yin Huang CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937026740 | K223064 | 000 |
| 00888937027587 | K223064 | 000 |