DeviceClearance

Product code QGG— Gastroenterology, Urology

BAROnova Access Sheath Kit

Classification name
Esophageal Sheath With Distal Balloon Anchor
Device class
Class 2
Regulation
21 CFR 876.1510
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QGG under 21 CFR 876.1510, via openFDA

Market context for product code QGG

FDA has cleared 1 device under product code QGG, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QGG

Recent clearances under product code QGG

Data sourced from openFDA. This site is unofficial and independent of the FDA.