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Magnetic Surgical System

FDA product code PNL · 7 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4815
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-06-06 – 2025-09-26

System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2. The device is intended for prescription use only.

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