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An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain itssue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.

An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction.

This is a 510(k) premarket notification for a medical device (endometrial suction curettes) and not a study describing the acceptance criteria or performance of an AI/ML powered device. Therefore, I cannot provide the requested information.

The document discusses the regulatory approval for "The Curette and Preferred Curette" and confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It outlines general controls, regulations, and reporting requirements for medical devices.

The "Indications for Use" section simply describes what the device is used for, which is to "remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction" for "biopsy precancer screening or ... menstrual extraction." This is a description of the device's intended clinical application, not a performance study with acceptance criteria for an algorithm.

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