Esophageal Dilator Balloon With Or Without Electrode Sensors
The Esophageal Dilator Balloon with or without Electrode Sensors is a gastroenterology device used to dilate the lower esophageal sphincter in patients with achalasia, potentially incorporating electrode sensors for additional physiological measurement 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) specialty. The product code is PID. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PID
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To dilate the lower esophageal sphincter of patients with Achalasia.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K182895 | Wilson-Cook Achalasia Balloon | Jan 25, 2019 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K132337 | ESOFLIP BALLOON DILATION CATHETER | Oct 07, 2013 | Substantially Equivalent | Crospon, Ltd. |
| K050232 | RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR | Mar 11, 2005 | Substantially Equivalent | Boston Scientific Corp |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.