510(k) K014166 ยท HIF Insufflator, Laparoscopic
UHI-3 HIGH FLOW INSUFFLATION UNIT
| Applicant | Olympus Optical Co., Ltd., Melville NY, US |
| Decision | Substantially Equivalent, Jun 25, 2002 |
| Received | Dec 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit. Model Number: UHI-3.
Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatme Open, Classified |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.