PENTAX

Device typeUltrasound endoscope balloon, synthetic polymer: A sterile balloon-like cap made of a synthetic-polymer (e.g., silicone) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.

FDA categoryEndoscopic ultrasound system, gastroenterology-urology

Device ID04961333253951

AvailabilityPrescription

Single useYes

SterileYes

LatexContains natural rubber latex

MRI safetyLabeling does not contain MRI Safety Information