Visera Hysterovideoscope Olympus HYF Type V
FDA 510(k) clearance K221557 · decided 2022-09-02
Clearance details
- K-number
- K221557
- Device name
- Visera Hysterovideoscope Olympus HYF Type V
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-05-31
- Decision date
- 2022-09-02
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. recall (Z-0336-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Visera Hysterovideoscope Olympus HYF Type V recall (Z-2480-2023) | Olympus Corporation of the Americas | 2023-08-29 |