510(k) K253702 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Intuitive Endoluminal Gastrointestinal System (IG1000)
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 7, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253702
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.