ALLY II Uterine Positioning System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223064 FDA 510(k)
- FDA Product Code
- LKF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ALLY II Uterine Positioning System is a table-mounted device classified as a cannula, manipulator/injector for uterine use. It is designed to secure uterine manipulator devices, providing controlled positioning and exposure of the uterus during operative and diagnostic gynecologic laparoscopy.
This system is intended for single-use in sterile surgical settings and is compatible with MRI environments. It includes various adapters and drapes for integration with uterine manipulators and is authorised under FDA 510K and MDR regulations. The device is supplied with specific model references and adapters to ensure proper mounting and positioning during procedures.
Frequently asked questions
What is the primary purpose of the ALLY II Uterine Positioning System in surgical settings?
The ALLY II Uterine Positioning System is designed to secure uterine manipulator devices during operative and diagnostic gynecologic laparoscopy. It provides controlled positioning and exposure of the uterus, ensuring stability and optimal visualization for procedures.
Is the ALLY II Uterine Positioning System compatible with MRI environments, and why does this matter?
Yes, the ALLY II Uterine Positioning System is explicitly designed to be compatible with MRI environments. This matters because it allows for safe use in facilities where MRI imaging is performed, reducing the risk of interference or damage to the device or equipment.
How is the ALLY II Uterine Positioning System supplied, and what components are included?
The ALLY II Uterine Positioning System is supplied as a single-use device for sterile surgical settings. It includes various adapters and drapes to ensure proper integration with uterine manipulators and secure mounting on the surgical table.
What regulatory pathways has the ALLY II Uterine Positioning System undergone, and what does this mean for its use?
The device has been authorized through the FDA 510K pathway and the EU’s Medical Device Regulation (MDR). This means it has undergone review by regulatory bodies to demonstrate substantial equivalence to existing devices and compliance with safety and performance standards, ensuring its suitability for clinical use in both the U.S. and EU markets.
Are there multiple model references or sizes available for the ALLY II Uterine Positioning System, and how does this affect compatibility?
Yes, the ALLY II Uterine Positioning System is available with multiple model references and adapters, as listed in the regulatory data. These variations ensure compatibility with different uterine manipulator devices, allowing clinicians to select the appropriate configuration for their specific surgical needs.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ALLY Uterine Positioning System™ - CooperSurgical, ALLY II Uterine Positioning System - CooperSurgical, CooperSurgical ALLY UPS
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223064 | Class II | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA 510(k) K223064 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026