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, Inc., Diversatek Healthcare and Alandra Medical Sapi DE CV.
3
Total
2
Cleared
248d
Avg days
2019
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Esophageal, Mucosal, Electrical Characterization Devices (Product Code QIS)
3 devices
Cleared
Sep 06, 2024
Mucosal Impedance Measurement System
Alandra Medical Sapi DE CV
Gastroenterology & Urology
266d
Cleared
Apr 25, 2023
MiVu™ Esophageal Endo Cap
Diversatek Healthcare
Gastroenterology & Urology
106d
Not Cleared
Dec 23, 2019
Mucosal Integrity Conductivity (MI) Test System
Diversatek Healthcare, Inc.
Gastroenterology & Urology
371d
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 declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.