Panels › Gastroenterology, Urology › Product code PID · Class 2
Esophageal Dilator Balloon With Or Without Electrode Sensors
Regulation 876.5980
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PID
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 1 | 0 |
| Covidien, LLC | 0 | 1 |
| Crospon, Ltd. | 1 | 0 |
| Wilson-Cook Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2019 | K182895 | Wilson-Cook Achalasia Balloon Wilson-Cook Medical, Inc. | PID |
| Oct 7, 2013 | K132337 | ESOFLIP BALLOON DILATION CATHETER Crospon, Ltd. | PID |
| Mar 11, 2005 | K050232 | RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR Boston Scientific Corp | PID |
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