510(k) K260965 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
CVAC Aspiration System
| Applicant | Calyxo, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 13, 2026 |
| Received | Mar 23, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260965
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.