SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM— 510(k) K120524

Name: FDA 510(k) clearance K120524
Creator: U.S. Food and Drug Administration
Published: 2012-06-21

Substantially Equivalent

Mui Scientific

FDA 510(k) clearance K120524 for SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM, Substantially Equivalent on 2012-06-21. Applicant: Mui Scientific. Device class: 2.

Clearance details

Applicant: Mui Scientific
Product code: Code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2012-02-22
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.