510(k) K953162 ยท HIF Insufflator, Laparoscopic
OLYMPUS HIGH FLOW INSUFFLATION UNIT
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Dec 19, 1995 |
| Received | Jul 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953162
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit. Model Number: UHI.
Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment Open, Classified |
HIF | None listed |
| Feb 18, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit. Model/ Number: UHI-2.
Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatm Open, Classified |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.