510(k) K252140 · EXB Collector, Ostomy
Heylo System
| Applicant | Coloplast Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 6, 2025 |
| Received | Jul 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252140
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.