title: Medical Devices; General and Plastic Surgery Devices;   Classification of the Magnetic Surgical Instrument System. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D013502:General Surgery / Q000145:classification / Q000295:instrumentation; D006801:Humans; D020706:Laparoscopes / Q000145:classification*; D060526:Magnetic Fields; D013518:Surgery, Plastic / Q000145:classification / Q000295:instrumentation; D013525:Surgical Instruments / Q000145:classification*; D014481:United States