Rapid Barostat Bag (RBB) Pump and Catheter System— 510(k) K262621

Name: FDA 510(k) clearance K262621
Creator: U.S. Food and Drug Administration
Published: 2026-09-30

Substantially Equivalent

Mui Scientific, Inc.

FDA 510(k) clearance K262621 for Rapid Barostat Bag (RBB) Pump and Catheter System, Substantially Equivalent on 2026-09-30. Applicant: Mui Scientific, Inc.. Device class: 2.

Summary

The Rapid Barostat Bag (RBB) Pump and Catheter System is filed under FFX, electrical gastrointestinal motility systems. The record doesn't describe how the system works or list its measurements or indications.

Class II, 21 CFR 876.1725, Gastroenterology and Urology panel. Mui Scientific, Inc. filed it as a Special 510(k).

Mui Scientific is in Mississauga, Canada. The clock ran 64 days (July 28 to September 30, 2026).

Clearance details

Applicant: Mui Scientific, Inc.
Product code: Product code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2026-07-28
Decision date: 2026-09-30
Decision: Substantially Equivalent
Clearance type: Special
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.