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U.S. Department of Health and Human Services

Product Classification
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Device tether accessory for use in the gastrointestinal tract
Definition A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract.
Physical State flexible tether
Technical Method Attaches to a parent device to maneuver the device in the gastrointestinal tract
Target Area Upper gastrointestinal tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQUN
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1305
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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