title: Medical Devices; Ear, Nose, and Throat Devices; Classification of   the External Upper Esophageal Sphincter Compression Device. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression device 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 external UES compression device'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*; D004869:Equipment Safety / Q000145:classification; D049631:Esophageal Sphincter, Upper; D006801:Humans; D057045:Laryngopharyngeal Reflux / Q000517:prevention & control; D010036:Otolaryngology / Q000145:classification* / Q000295:instrumentation*; D014481:United States