510(k) K252605 ยท FFX System, Gastrointestinal Motility (Electrical)
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
| Applicant | Medspira, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 5, 2025 |
| Received | Aug 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252605
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.