510(k) K240978 · HIH Hysteroscope (And Accessories)
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
| Applicant | MacroLux Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 16, 2024 |
| Received | Apr 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240978
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.