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# FDA Draft Guide on Ultrasonic Surgical Aspirators
- URL: https://www.fdaweb.com/fda-draft-guide-on-ultrasonic-surgical-aspirators/
- Published: 2016-11-09T12:00:00.000Z
- Updated: 2026-09-14T21:46:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137304

FDA has released a draft guidance document on [Product Labeling for Certain Ultrasonic Surgical Aspirator Devices](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTYxMTA5LjY2MTA5MzAxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MTEwOS42NjEwOTMwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MzYyNTI0JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM528182.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) that provides labeling recommendations to promote the safe and effective use of aspirators. Ultrasonic surgical aspirator devices (aspirators) are surgical tools commonly used for a wide range of procedures to break down, liquefy, and remove hard and soft tissue. The document specifically recommends that manufacturers of these devices with a general indication for use in general surgery, laparoscopy, or gynecologic surgery do the following:

- include a contraindication in their product labeling that states that the device should not be used to remove uterine fibroids; and
- review and update other portions of their device’s labeling to be consistent with this contraindication.

FDA notes that the draft only applies to ultrasonic surgical aspirator devices intended for use in general surgery, laparoscopy, and gynecologic surgery. It does not apply to aspirators specifically indicated for other surgical subspecialties, such as gastrointestinal and affiliated organ surgery, urological surgery, and neurosurgery.