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Endometrial Sampling Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040189

by Rocket Medical Plc

Identifiers

510(k) Number
K040189 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 Endometrial Sampling Syringe is a Curette, Suction, Endometrial (and Accessories) as classified under CFR 884.1175. This device is designed for the collection of endometrial tissue samples, facilitating diagnostic procedures in obstetrics and gynecology. It combines suction and curette mechanisms to safely obtain tissue for histopathological examination, aiding in the evaluation of conditions such as abnormal uterine bleeding or infertility.

The device is supplied as a single-use medical instrument, intended for use in clinical settings by trained healthcare professionals. It is not sterile upon packaging but is intended to be sterilized prior to use, adhering to standard medical device sterilization protocols. The Endometrial Sampling Syringe has received FDA 510(k) clearance under the Traditional 510(k) review pathway, with a classification as a Class II device. No specific MRI safety information is provided, and sizes or additional technical specifications are not detailed in the available data.

Frequently asked questions

What is the Endometrial Sampling Syringe used for?

The Endometrial Sampling Syringe is designed for collecting endometrial tissue samples during diagnostic procedures in obstetrics and gynecology. It combines suction and curette mechanisms to safely obtain tissue, which is then examined histopathologically. This aids in diagnosing conditions such as abnormal uterine bleeding or infertility by providing tissue for detailed laboratory analysis.

Is the Endometrial Sampling Syringe single-use or reusable?

The Endometrial Sampling Syringe is intended for single-use only. It is not sterile upon packaging and must be sterilized prior to use according to standard medical device protocols. This ensures patient safety and prevents cross-contamination between procedures.

How should the Endometrial Sampling Syringe be stored?

While specific storage instructions are not detailed in the available data, single-use medical devices like this syringe should generally be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Ensure the packaging remains intact until sterilization and use to maintain sterility and functionality.

What regulatory pathway was followed for this device?

The Endometrial Sampling Syringe received FDA 510(k) clearance under the Traditional 510(k) review pathway. This classification confirms it is substantially equivalent to a legally marketed predicate device and is categorized as a Class II medical device, indicating moderate regulatory oversight.

Are there any specific sizes or technical specifications mentioned for this device?

The provided data does not include detailed technical specifications such as sizes or additional technical features for the Endometrial Sampling Syringe. For precise specifications, refer to the manufacturer’s instructions or technical documentation accompanying the device.

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: ENDOMETRIAL SAMPLING SYRINGE (K040189) — FDA 510(k) | Innolitics, Home - Rocket Medical, ENDOMETRIAL SAMPLING SYRINGE 510 (k) K040189 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rocket Medical Plc

Sources (1)

  • FDA 510(k) K040189 24 fields · synced Oct 1, 2026