Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Esophageal Dilator With Balloon And Electrode Sensors

FDA product code PIE · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5980
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-11-22 – 2017-11-22

To dilate esophageal strictures with a dilating balloon and electrode sensors.

↑