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Esophageal Sheath With Distal Balloon Anchor

Esophageal Sheath With Distal Balloon Anchor is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Esophageal Sheath With Distal Balloon Anchor
Gastroenterology, Urology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QGG

View Product Code Classification

Class 2

21 CFR 876.1510

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Gastroenterology, Urology

Device Characteristics

No

No

No

Not Eligible

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.