mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)— 510(k) K252605

Name: FDA 510(k) clearance K252605
Creator: U.S. Food and Drug Administration
Published: 2025-12-05

Substantially Equivalent

Medspira, LLC

FDA 510(k) clearance K252605 for mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001), Substantially Equivalent on 2025-12-05. Applicant: Medspira, LLC. Device class: 2.

Clearance details

Applicant: Medspira, LLC
Product code: Code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-18
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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.