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

Esophageal Dilator Balloon With Or Without Electrode Sensors

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

PID is the FDA product code for Esophageal Dilator Balloon With Or Without Electrode Sensors, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "To dilate the lower esophageal sphincter of patients with Achalasia". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PID
Device name
Esophageal Dilator Balloon With Or Without Electrode Sensors
FDA definition
To dilate the lower esophageal sphincter of patients with Achalasia.
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
3
Ingested recalls
1

Clearances, product code PID

By decision year
3 clearances under product code PID with a decision year between 2005 and 2019, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PID by decision year
YearClearances
20051
20131
20191

Applicants with the most clearances

Product code PID
Applicants holding the most 510(k) clearances under product code PID
ApplicantClearances
Boston Scientific Corporation1
Crospon, Ltd.1
Wilson-Cook Medical Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code