QGG

Esophageal Sheath With Distal Balloon Anchor

Product code

QGG

Device name

Esophageal Sheath With Distal Balloon Anchor

Device class

Class 2

21 CFR

21 CFR 876.1510

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device.

Definition text from the FDA device classification database (U.S. federal government work, public domain).