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Uterine Manipulator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172846

by Beijing HangTian KaDi Technology R&D Institute

Identifiers

510(k) Number
K172846 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 Manipulator is a medical device classified as a cannula, manipulator, or injector for uterine procedures. It is designed to assist in positioning and stabilizing the uterus during surgical interventions, such as hysteroscopy or other gynecological procedures, ensuring optimal access and visualization of the uterine cavity.

This device is supplied as a single-use instrument and is intended for use in clinical settings by trained healthcare professionals. It is not MRI-safe and must be handled with sterile techniques. The manipulator is available in multiple reference codes (e.g., 3030447506, 1825146) and is regulated under FDA 510(k) clearance (K172846) as substantially equivalent to predicate devices. Storage and handling must comply with standard medical device protocols to maintain sterility and functionality.

Frequently asked questions

What is the primary purpose of the Uterine Manipulator during surgical procedures?

The Uterine Manipulator is designed to assist in positioning and stabilizing the uterus during surgical interventions like hysteroscopy or other gynecological procedures. This ensures optimal access and visualization of the uterine cavity, improving the precision and safety of the procedure.

Is the Uterine Manipulator intended for reuse or is it single-use only?

The Uterine Manipulator is explicitly supplied as a single-use instrument. This design choice aligns with standard medical device protocols to maintain sterility and prevent cross-contamination between patients.

How should the Uterine Manipulator be stored to ensure proper functionality and sterility?

The device must be stored and handled according to standard medical device protocols to preserve sterility and functionality. Since it is single-use, it should remain in its original, unopened packaging until immediately before use, following manufacturer guidelines for sterile storage conditions.

What regulatory pathway was followed for FDA clearance of this device?

The Uterine Manipulator received FDA 510(k) clearance (K172846) under the Traditional 510(k) Review pathway. It was determined to be substantially equivalent to predicate devices, with the review conducted by the Obstetrics/Gynecology (OB) Advisory Committee. The device falls under product code LKF and regulation number 884.4530.

Are there multiple sizes or models available for the Uterine Manipulator?

Yes, the Uterine Manipulator is available in multiple reference codes, including 1825146, 3030447506, and dozens of others listed under the registration numbers. These variations may correspond to different sizes, lengths, or configurations to accommodate varying clinical needs, though exact specifications would require consulting the manufacturer’s documentation.

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: Beijing Hangtian Kadi Technology R&d Institute, Beijing Hangtian Kadi Technology R&d Institute - Soft Tissue Retractor ..., EC21 - Beijing HangTian KaDi Technology R&D Institute, Uterine Manipulator (K172846) - FDA 510 (k), Beijing HangTian KaDi Technology R & D Institute Co. Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Beijing HangTian KaDi Technology R&D Institute

Sources (1)

  • FDA 510(k) K172846 24 fields · synced Oct 6, 2026