EZC Medical, LLC, announced that it has received 510(k) clearance for its Intubaid Flex. It is an airway management and visualization device which is intended to be used as an aid in the placement of an Endotracheal Tube (ETT) directly or through an Intubating Laryngeal Mask during non difficult and difficult intubation procedures.
The Intubaid Flex provides the user with a visual confirmation of where the tip of the device is in the human anatomy. The flexible tip of the device allows the user to guide the ETT in the desired direction. FDA clearance of our 510(k) is important to physicians and patients alike because it acknowledges the value of the IntubaidFlex in helping physicians, particularly during difficult intubation procedures, said Jerry Sanders, Managing Director & CEO of EZC Medical.
We are excited about the demonstrated capability of our device and its potential for saving lives, said Dr. Pavan Sethi, Vice President Regulatory, Quality and Scientific Affairs at EZC Medical.