HIGH FLOW INSUFFLATION UNIT UHI-4— 510(k) K110294
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K110294 for HIGH FLOW INSUFFLATION UNIT UHI-4, Substantially Equivalent on 2011-11-18. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Recent devices under product code HIF
view allMore clearances from Olympus Medical Systems Corporation
view all- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
- K260856 — Disposable Distal Attachment D-201-13404
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
Adverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110294
K-number listed on FDA's recall record- Z-1375-2024 — Insufflation unit, UHI-4.
- Z-0075-2024 — Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110294.
Data sourced from openFDA. This site is unofficial and independent of the FDA.