Product Classification

• Device: esophageal dilator with balloon and electrode sensors
• Regulation Description: Gastrointestinal tube and accessories.
• Definition: To dilate esophageal strictures with a dilating balloon and electrode sensors.
• Physical State: balloon with electrode sensors and software
• Technical Method: balloon with electrode sensors
• Target Area: esophagus
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: PIE
• 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