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

Esophageal, Mucosal, Electrical Characterization

21 CFR 876.1450 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QIS is the FDA product code for Esophageal, Mucosal, Electrical Characterization, a class II device type, regulated under 21 CFR 876.1450. FDA's definition for this code reads: "The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QIS
Device name
Esophageal, Mucosal, Electrical Characterization
FDA definition
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Regulation
21 CFR 876.1450
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
0

Clearances, product code QIS

By decision year
3 clearances under product code QIS with a decision year between 2019 and 2024, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QIS by decision year
YearClearances
20191
20231
20241

Applicants with the most clearances

Product code QIS
Applicants holding the most 510(k) clearances under product code QIS
ApplicantClearances
Diversatek Healthcare Inc2
Alandra Medical Sapi de CV1

Companies listing this code with FDA

Companies whose registered establishments list this code