510(k) K252605
K252605 is an FDA 510(k) premarket notification submitted by Medspira, LLC for the device "mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)". The FDA issued a decision of Substantially Equivalent on December 5, 2025. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Medspira, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2025
- Date Received
- August 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Gastrointestinal Motility (Electrical)
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type