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U.S. Department of Health and Human Services

Product Classification

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Device magnetic surgical system
Regulation Description Magnetic surgical instrument system.
Definition 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.
Physical State The device is two different instruments, the magnetic controller which is outside of the body and is 3x2 inches, oval-shaped with handles and is a large magnet made of NdFeB, Grade N42 disk magnet. The second instrument is the detachable grasper which is magnetic and actuated via its pistol-grip handle with two distinct scissor-type motions to open and close the detachable grasper jaws.
Technical Method Uses a detachable grasper that can be attracted with a magnet that goes into the body to grasp and retract the gallbladder. Externally, a large magnet is kept outside of the body to hold the detachable grasper in place during surgery with its magnetic field strength.
Target Area The magnetic controller is kept external to the body on the abdomen. The detachable grasper is used during laparoscopic cholecystectomy to grasp and retract the gallbladder inside the body.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePNL
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4815
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible