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U.S. Department of Health and Human Services

Product Classification
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Device esophageal dilator balloon with or without electrode sensors
Regulation Description Gastrointestinal tube and accessories.
Definition To dilate the lower esophageal sphincter of patients with Achalasia.
Physical State Tube and Balloon with or without electrode sensors and software.
Technical Method Tube and Balloon with or without electrode sensors.
Target Area lower esophageal sphincter
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePID
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 876.5980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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