Data / Medical devices / Esophageal Dilator Balloon With Or Without Electrode Sensors
Esophageal Dilator Balloon With Or Without Electrode Sensors (PID): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Esophageal Dilator Balloon With Or Without Electrode Sensors (product code PID, Class 2, 21 CFR 876.5980). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on January 25, 2019, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PID
- Device class
- 2
- Regulation
- 876.5980
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
| Costa Rica | 1 |
Makers of Esophageal Dilator Balloon With Or Without Electrode Sensors
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | March 11, 2005 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | March 11, 2005 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer, Manufacturer | 1 | October 7, 2013 | 0 | 0 | 0 | api.fda.gov |
| Covidien llc | Santa Clara, CA, United States | Specification developer | 1 | October 7, 2013 | 0 | 1 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 1 | January 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Creganna Medical S. R. L | San Rafael Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 25, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.