FDA product code QUN

Tether Accessory For Use In The Gastrointestinal Tract

Gastroenterology, Urology·Class 2·21 CFR 876.1305
US regulatory classifications
US Product Code (FDA)
QUN
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.1305
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract.

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About this record

Tether Accessory For Use In The Gastrointestinal Tract 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.