K252605
- 510(k) number
- K252605
- Device name
- mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
- Applicant
- Medspira, LLC MN · US
- Product code
- FFX — System, Gastrointestinal Motility (Electrical)
- Decision date
- 2025-12-05
- Date received
- 2025-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252605.pdf
Official FDA record: K252605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.