Medical Devices; Gastroenterology-Urology Devices; Classification of the Magnetically Maneuvered Capsule Endoscopy System
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the magnetically maneuvered capsule endoscopy system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the magnetically maneuvered capsule endoscopy system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
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