510(k) K253550 ยท SAH Magnetic Compression Anastomosis System
Self-Forming Magnet (Flexagon Plus OTOLoc)
| Applicant | GI Windows, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jan 9, 2026 |
| Received | Nov 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253550
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.