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Esophageal Sheath With Distal Balloon Anchor

FDA product code QGG · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1510
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-07-22 – 2019-07-22

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.

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