510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233974Substantially Equivalent

Mucosal Impedance Measurement System

Alandra Medical Sapi de CV, Mexico City, MX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233974 is the FDA 510(k) clearance record for Mucosal Impedance Measurement System, a class II device, cleared for Alandra Medical Sapi DE CV on under FDA product code QIS (Esophageal, Mucosal, Electrical Characterization). FDA's definition for product code QIS reads: "The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue". FDA records list one 510(k) clearance for Alandra Medical Sapi DE CV. As of , FDA records show no recalls naming K233974.

Clearance record

Decision date
Received
(266 days to decision)
Product code
QIS Esophageal, Mucosal, Electrical Characterization
Regulation
21 CFR 876.1450
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Alandra Medical Sapi DE CV Bosque De Alisos 17, Oficina 7, Mexico City, MX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QIS

Trailing 12 months

FDA records hold no clearances under product code QIS in the trailing twelve months.

FDA records show no clearances under product code QIS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QIS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260