OLYMPUS HIGH FLOW INSUFFLATION UNIT
FDA 510(k) clearance K953162 · decided 1995-12-19
Clearance details
- K-number
- K953162
- Device name
- OLYMPUS HIGH FLOW INSUFFLATION UNIT
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-07
- Decision date
- 1995-12-19
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdom recall (Z-1352-2026) | Olympus Corporation of the Americas | 2026-02-18 |
| Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the ab recall (Z-1353-2026) | Olympus Corporation of the Americas | 2026-02-18 |