High Flow Insufflation Unit (UHI-4)
FDA 510(k) clearance K243527 · decided 2025-01-13
Clearance details
- K-number
- K243527
- Device name
- High Flow Insufflation Unit (UHI-4)
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-11-14
- Decision date
- 2025-01-13
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 recall (Z-2776-2026) | Olympus Corporation of the Americas | 2026-07-22 |