510(k) K243527 ยท HIF Insufflator, Laparoscopic
High Flow Insufflation Unit (UHI-4)
| Applicant | Olympus Medical Systems Corporation, Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Jan 13, 2025 |
| Received | Nov 14, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243527
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 Open, Classified |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.