510(k) K250645 ยท FER Anoscope And Accessories
SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
| Applicant | Haemoband Surgical, Ltd., Belfast, GB |
| Decision | Substantially Equivalent, Oct 9, 2025 |
| Received | Mar 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250645
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.