QGG · Class II · 21 CFR 876.1510

FDA Product Code QGG: Esophageal Sheath With Distal Balloon Anchor

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.

Leading manufacturers include Baronova, Inc..

1
Total
1
Cleared
90d
Avg days
2019
Since

FDA 510(k) Cleared Esophageal Sheath With Distal Balloon Anchor Devices (Product Code QGG)

1 devices
1–1 of 1
Cleared Jul 22, 2019
BAROnova Access Sheath Kit
K191078
Baronova, Inc.
Gastroenterology & Urology · 90d

About Product Code QGG - Regulatory Context