510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PIEClass II

Esophageal Dilator With Balloon And Electrode Sensors

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PIE is the FDA product code for Esophageal Dilator With Balloon And Electrode Sensors, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "To dilate esophageal strictures with a dilating balloon and electrode sensors". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PIE
Device name
Esophageal Dilator With Balloon And Electrode Sensors
FDA definition
To dilate esophageal strictures with a dilating balloon and electrode sensors.
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PIE

By decision year
2 clearances under product code PIE with a decision year between 2014 and 2017, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PIE by decision year
YearClearances
20141
20171

Applicants with the most clearances

Product code PIE
Applicants holding the most 510(k) clearances under product code PIE
ApplicantClearances
Crospon, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code