Panels › Gastroenterology, Urology › Product code PIE · Class 2
Esophageal Dilator With Balloon And Electrode Sensors
Regulation 876.5980
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PIE
| Company | 510(k)s | Recalls |
|---|---|---|
| Crospon, Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 2017 | K172128 | EsoFLIP® ES-310 Balloon Catheter Crospon, Ltd., IE | PIE |
| Sep 25, 2014 | K142000 | ESOFLIP ES Crospon, Ltd. | PIE |
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