Identifiers
- 510(k) Number
- K904079 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 Bard Uterine Manipulator LKF is a cannula, manipulator/injector, uterine (per FDA nomenclature), designed to facilitate access to the uterine cavity. It is used to engage and adjust the cervix, enabling passage through the cervical canal into the uterus for diagnostic or therapeutic procedures. The device is intended for controlled manipulation during obstetric or gynecological interventions where uterine access is required.
This device is supplied as a single-use, non-sterile instrument and is classified as a Class II medical device under FDA regulations (884.4530). It is intended for use in clinical settings such as operating rooms or procedural suites, where aseptic techniques are applied. The manipulator is regulated under FDA 510(k) clearance (K904079) and is intended for obstetrics/gynecology applications, as reviewed by the Obstetrics/Gynecology Advisory Committee. No MRI safety information is specified.
Frequently asked questions
What is the Bard Uterine Manipulator LKF used for?
The Bard Uterine Manipulator LKF is designed to facilitate access to the uterine cavity by engaging and adjusting the cervix. This allows passage through the cervical canal into the uterus for diagnostic or therapeutic procedures, such as hysteroscopy or other obstetric/gynecological interventions where precise uterine access is required.
Is the Bard Uterine Manipulator LKF sterile?
No, the Bard Uterine Manipulator LKF is supplied as a non-sterile instrument. It is intended for use in clinical settings where aseptic techniques are applied, such as operating rooms or procedural suites, to ensure sterility during the procedure itself.
How is the Bard Uterine Manipulator LKF supplied?
The device is supplied as a single-use item, meaning it is intended for one-time use only. This design ensures patient safety and reduces the risk of cross-contamination between procedures.
What regulatory pathway does the Bard Uterine Manipulator LKF follow?
The Bard Uterine Manipulator LKF is classified as a Class II medical device under FDA regulations (884.4530) and has received FDA 510(k) clearance (K904079). It was reviewed by the Obstetrics/Gynecology Advisory Committee and determined to be substantially equivalent to a predicate device.
Can the Bard Uterine Manipulator LKF be reused?
No, the Bard Uterine Manipulator LKF is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise patient safety and device integrity.
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: BARD UTERINE MANIPULATOR (K904079) — FDA 510 (k) | Innolitics, Uterine access device with automatic cervical adjustment - C. R. Bard, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904079 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K904079 24 fields · synced Oct 1, 2026