510(k) K243750 ยท OCW Endoscopic Tissue Approximation Device
SimpleStitch Suturing System
| Applicant | Envision Endoscopy, Waltham MA, US |
| Decision | Substantially Equivalent, Apr 17, 2025 |
| Received | Dec 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243750
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.