510(k) K110294 ยท HIF Insufflator, Laparoscopic
HIGH FLOW INSUFFLATION UNIT UHI-4
| Applicant | Olympus Medical Systems Corporation, Center Valley PA, US |
| Decision | Substantially Equivalent, Nov 18, 2011 |
| Received | Feb 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110294
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2024 | Olympus Corporation of the Americas Insufflation unit, UHI-4. Open, Classified |
HIF | None listed |
| Oct 18, 2023 | Olympus Corporation of the Americas Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. Open, Classified |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.