Esophageal Dilator With Balloon And Electrode Sensors
The Esophageal Dilator with Balloon and Electrode Sensors is a combined therapeutic and diagnostic device used to dilate esophageal strictures with a dilating balloon while electrode sensors provide simultaneous physiological monitoring during the procedure. It is an FDA Class 2 device regulated under 21 CFR 876.5980, requiring 510(k) premarket notification, within the Gastroenterology and Urology (GU) medical specialty. The product code is PIE. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PIE
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To dilate esophageal strictures with a dilating balloon and electrode sensors.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.