FDA product code PIE: Esophageal Dilator With Balloon And Electrode Sensors
PIE is the FDA product code for esophageal dilator with balloon and electrode sensors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under PIE. The average 510(k) review took 98 days (median 98).
Definition
To dilate esophageal strictures with a dilating balloon and electrode sensors.
Classification
| Field | Value |
|---|---|
| Device name | Esophageal Dilator With Balloon And Electrode Sensors |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PIE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 131 |
Compare with all 510(k) review times · Search every PIE clearance
Top PIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crospon, Ltd. | 2 | 2017-11-22 |
Most recent PIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172128 | Crospon, Ltd. | EsoFLIP® ES-310 Balloon Catheter | 2017-11-22 | 131 |
| K142000 | Crospon, Ltd. | ESOFLIP ES | 2014-09-25 | 64 |
Recalls for PIE devices
openFDA lists no recalls for product code PIE.
Frequently asked questions
What is FDA product code PIE?
PIE is the FDA product code for esophageal dilator with balloon and electrode sensors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is PIE?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIE?
Across 2 cleared submissions the average was 98 days from receipt to decision (median 98).
Which companies have the most PIE clearances?
Crospon, Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PIE
- Run a recall and safety report across every PIE manufacturer
- Watch product code PIE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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