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Colposcope System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160341

by Xuzhou Kernel Medical Equipment Co., Ltd.

Identifiers

510(k) Number
K160341 FDA 510(k)
FDA Product Code
HEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1630 FDA 510(k)
Regulation Number
884.1630 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Colposcope System is a diagnostic device classified as a colposcope or colpomicroscope, designed for the examination of the cervix, vagina, and vulva. It provides magnified, illuminated views of tissue to detect abnormalities such as dysplasia, cervical cancer, or other gynecological conditions, aiding in targeted biopsy procedures.

This system is intended for use in clinical settings, including obstetrics and gynecology, and is supplied as a reusable medical device. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a classification as a Class II device. The system requires proper maintenance and sterilization between uses to ensure patient safety and device performance.

Frequently asked questions

What clinical specialties primarily use this colposcope system, and why is it relevant to them?

The Colposcope System is primarily used in obstetrics and gynecology settings. It is designed to provide magnified, illuminated views of the cervix, vagina, and vulva, which helps clinicians detect abnormalities such as dysplasia or cervical cancer. This aids in targeted biopsy procedures, making it essential for early diagnosis and treatment planning in gynecological care.

Is this colposcope system intended for single-use or reusable applications, and what maintenance is required?

The Colposcope System is supplied as a reusable medical device. To ensure patient safety and maintain performance, it requires proper maintenance and sterilization between uses. This includes cleaning, disinfection, and adherence to sterilization protocols as recommended by the manufacturer.

What regulatory pathways has this device undergone, and what does that mean for its use in clinical settings?

The Colposcope System has undergone FDA 510(k) clearance and is compliant with the EU Medical Device Regulation (MDR), classified as a Class II device. This means it has been evaluated for safety and effectiveness by regulatory authorities, ensuring it meets established standards for use in clinical settings, including obstetrics and gynecology.

How does the colposcope system assist in identifying potential gynecological conditions?

The Colposcope System provides magnified and illuminated views of the cervix, vagina, and vulva, allowing clinicians to closely examine tissue for abnormalities such as dysplasia or signs of cervical cancer. This enhanced visualization aids in identifying early-stage conditions, guiding targeted biopsies, and facilitating accurate diagnosis.

What types of sterilization methods are recommended for this reusable device?

While the specific sterilization methods aren’t detailed in the data, the Colposcope System is designed for reuse and requires proper sterilization between uses to prevent cross-contamination. Common methods for reusable medical devices like this include autoclaving, ethylene oxide sterilization, or other validated sterilization techniques as outlined in the manufacturer’s instructions for 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xuzhou Kernel Medical Equipment Co., Ltd.

Sources (2)

  • FDA 510(k) K160341 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026