Uterine ElevatOR PRO with OccludOR Balloon
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220202 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 Uterine Elevator Pro with Occluder Balloon is a Cannula, Manipulator/Injector, Uterine, designed for obstetric and gynecological procedures. It combines an elevator mechanism with an inflatable occluder balloon to facilitate controlled uterine positioning and isolation during interventions such as myolysis or fibroid treatment.
This device is intended for single-use in sterile clinical settings, including operating rooms or procedural suites. Supplied sterile and packaged individually, it adheres to FDA 510(k) clearance and MDR requirements, with a Class II regulatory classification. Multiple reference codes (e.g., 1825146, 3030447506) correspond to its regulatory submissions under registration number 884.4530.
Frequently asked questions
What clinical procedures is the Uterine Elevator Pro with Occluder Balloon primarily designed to assist with?
The Uterine Elevator Pro with Occluder Balloon is specifically designed to assist in obstetric and gynecological procedures such as myolysis or fibroid treatment. Its elevator mechanism and inflatable occluder balloon help facilitate controlled uterine positioning and isolation during these interventions, ensuring precision and stability.
Is the Uterine Elevator Pro with Occluder Balloon intended for reuse in clinical settings, or is it single-use?
The device is explicitly intended for single-use only in sterile clinical settings like operating rooms or procedural suites. It is supplied sterile and packaged individually to ensure safety and compliance with clinical protocols.
How is the Uterine Elevator Pro with Occluder Balloon regulated, and what classification does it fall under?
The device holds a Class II regulatory classification and has undergone FDA 510(k) clearance as well as compliance with the Medical Device Regulation (MDR). Its submissions are filed under registration number 884.4530, reflecting its obstetrics/gynecology specialty and substantial equivalence determination.
What types of packaging and storage conditions should be observed for this device?
The Uterine Elevator Pro with Occluder Balloon is supplied sterile and individually packaged to maintain integrity. While specific storage conditions aren’t detailed, standard sterile medical device storage practices—such as protecting from moisture, extreme temperatures, and physical damage—should be followed to preserve functionality until use.
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: Uterine fibroids - Symptoms and causes - Mayo Clinic
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 | K220202 | Class II | Active |
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Manufacturer
- Manufacturer
- The O R Company Pty Ltd
- FDA Applicant
- The O R Company Pty, Ltd.
Sources (2)
- FDA 510(k) K220202 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026