510(k) K243152 ยท HEW Culdoscope (And Accessories)
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Oct 2, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243152
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.