510(k) K243722 ยท OMT Absorbable Lung Biopsy Plug
Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)
| Applicant | Selio Medical Limited, Dublin, IE |
| Decision | Substantially Equivalent, Apr 8, 2025 |
| Received | Dec 3, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243722
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.