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# New Use Cleared for Levita Magnetic Surgical Device
- URL: https://www.fdaweb.com/new-use-cleared-for-levita-magnetic-surgical-device/
- Published: 2018-10-22T12:00:00.000Z
- Updated: 2026-09-15T00:39:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142640

FDA has cleared a Levita Magnetics 510(k) for an expanded indication to market the company’s Levita Magnetic Surgical System for use in bariatric procedures. Previously, the device was indicated for use in gallbladder removal procedures. It is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures and the liver in bariatric procedures to facilitate access and visualization of the surgical site. The system comprises an external magnet placed on the skin that controls a shaftless detachable grasper, which enables instruments to move without the constraints of a fixed-position pivot point, Levita Magnetics says.

  
“In conventional laparoscopic procedures, shafted surgical instruments are introduced by fixed-position trocars inserted through incisions in the abdomen,” the company says. Trocar use is associated with risks relating to major bowel and vessel injury, incisional pain, bleeding, scarring, hernias and infection. “The shaftless Levita System reduces the number of incisions and trocars necessary, while also providing surgeons the ability to move instruments without the constraints of a fixed-position pivot point,” it adds.