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Curette, Suction, Endometrial (CUTEQ 2.5)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020628

by Bioteque America, Inc.

Identifiers

510(k) Number
K020628 FDA 510(k)
FDA Product Code
HHK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1175 FDA 510(k)
Regulation Number
884.1175 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Curette, Suction, Endometrial (CUTEQ 2.5) is a medical device designed for endometrial sampling. It combines suction and curettage techniques to collect tissue from the uterine lining, aiding in diagnostic procedures such as evaluating abnormal uterine bleeding or assessing infertility. This device falls under the classification of an endometrial suction curette and its accessories, as defined by regulatory standards.

This device is intended for single-use in clinical settings, including obstetrics and gynecology. Supplied sterile, it is regulated under 21 CFR 884.1175 and classified as a Class II medical device (Product Code HHK). It is intended for use by healthcare professionals in outpatient or inpatient environments, adhering to standard aseptic techniques. No MRI safety information is specified, and storage conditions are not detailed in the regulatory data.

Frequently asked questions

What is the CUTEQ 2.5 used for in clinical settings?

The CUTEQ 2.5 is an endometrial suction curette designed to collect tissue from the uterine lining through a combination of suction and curettage techniques. It is primarily used for diagnostic procedures such as evaluating abnormal uterine bleeding or assessing infertility. This device helps healthcare professionals obtain tissue samples for histopathological examination, ensuring accurate diagnosis and treatment planning.

Is the CUTEQ 2.5 intended for single-use or reuse?

The CUTEQ 2.5 is explicitly designed for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in clinical settings like obstetrics and gynecology. Single-use devices are also aligned with best practices for infection control and regulatory standards.

How is the CUTEQ 2.5 supplied, and what sterility guarantees does it offer?

The CUTEQ 2.5 is supplied sterile, meaning it undergoes manufacturing and packaging processes that ensure it is free from harmful microorganisms before use. This sterility is essential for clinical procedures to minimize infection risks. The device adheres to standard aseptic techniques required for endometrial sampling, ensuring safe and reliable performance in both outpatient and inpatient environments.

What regulatory classification and approval does the CUTEQ 2.5 hold?

The CUTEQ 2.5 is classified as a Class II medical device under the FDA’s regulatory framework, specifically listed under product code HHK for endometrial suction curettes and accessories. It holds a 510(k) clearance from the FDA, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This classification reflects its role in diagnostic procedures and compliance with stringent safety and performance standards.

Are there specific storage instructions or conditions mentioned for the CUTEQ 2.5?

The provided regulatory data does not specify detailed storage conditions for the CUTEQ 2.5. However, as a sterile, single-use device, it should generally be stored in a clean, dry environment protected from contamination, extreme temperatures, and direct sunlight. Healthcare facilities should follow standard protocols for maintaining the integrity of sterile medical devices 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: CURELLE, PREFERRED CURELLE, CUTEQ 2.5 - Innolitics, Products — Bioteque America, fda.innolitics.com, Device Listing 1958591772 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bioteque America, Inc.

Sources (1)

  • FDA 510(k) K020628 24 fields · synced Oct 1, 2026