21 CFR § 868.5650
Esophageal obturator
June 25, 2020
(a) Identification. An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency resuscitation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The device consists of a closed-end semirigid esophageal tube that is attached to a face mask.
(b) Classification. Class II (performance standards).