FDA Product Code QIS: Esophageal, Mucosal, Electrical Characterization
The Esophageal Tissue Characterization System Is Intended For Obtaining Measurements Of Electrical Properties Within Esophageal Tissue.
Leading manufacturers include Diversatek Healthcare and Alandra Medical Sapi DE CV.
FDA 510(k) Cleared Esophageal, Mucosal, Electrical Characterization Devices (Product Code QIS)
About Product Code QIS - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QIS since 2019, with 2 receiving FDA clearance (average review time: 248 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for QIS submissions have been consistent, averaging 266 days recently vs 239 days historically.
QIS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →